Clinical trial NCT03566823: Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Official title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 306)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.

Detailed description: 27Mar2020: Enrollment of new patients into this study has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic .

Eligibility criteria: Inclusion Criteria:

* Participants must be between greater than or equal to (\> =) 16 and less than or equal to (\<=) 80 years of age; participants less than (\<) 18 years of age must weigh \>=40 kg and must have body mass index \>=16.5 kilogram per meter square (kg/m\^2)
* Participants must have active moderate to severe ileal (terminal ileum), ileocolic, or colonic CD at baseline (Visit 2) as defined by:

  1. CDAI score between 220 and 450 (inclusive) AND
  2. Meeting the following subscores in the 2 item PRO:

  i. Abdominal pain subscore \>= 5 (average worst daily pain on the 11 point NRS) and abdominal pain subscore \>= 2 (average daily pain on the 4-point abdominal pain variable of CDAI) over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) AND/OR ii. Average of the daily stool frequency subscore \>=4 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days out of the 10 days before colonoscopy preparation (may or may not be contiguous) c. Presence of ulcerations that are characteristic to CD, as determined by a colonoscopy performed during screening, and as defined by the SES-CD \>6 (SES CD \>=4 for isolated ileitis) Note that the participant must be confirmed as meeting the CDAI score and PRO subscore requirements before a colonoscopy is done
* Participants must have a documented diagnosis (endoscopic with histology) of CD for \>=3 months before screening. Documented diagnosis is defined as:

  1. A biopsy report in which the description of the histological findings is consistent with the CD diagnosis AND
  2. A report documenting disease duration based upon prior colonoscopy Note: If a biopsy report is not available in the source document at the time of screening, a biopsy must be performed during the screening colonoscopy and the histology report should be consistent with the CD diagnosis. If the histology description does not support the CD diagnosis at this time point, the participant should not be randomized
* Participants must be willing and able to undergo a colonoscopy during screening after all other inclusion criteria have been met
* Participants must have had an inadequate response to, or lost response to, or had an intolerance to at least 1 conventional treatment such as sulfasalazine or mesalamine (5-aminosalicylic acid \[5-ASA\]), glucocorticoids, or immunosuppressants (azathioprine \[AZA\], 6-mercaptopurine \[6-MP\] or methotrexate \[MTX\]) or anti-tumor necrosis factor (anti-TNF). Participants who have had an inadequate response to sulfasalazine or mesalamine should have also failed at least 1 other conventional treatment such as glucocorticoids
* Participants receiving any treatment(s) for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time
* Participants are males or nonpregnant, nonlactating females who, if sexually active, agree to comply with the contraceptive requirements of the protocol, or females of nonchildbearing potential. Males and females of reproductive potential who are sexually active must agree to use appropriate contraception (ie, highly effective methods for female and medically appropriate methods for male study participants, for the duration of the study

Exclusion criteria:

* Participants with indeterminate colitis, microscopic colitis, nonsteroidal anti-inflammatory drug-induced colitis, ischemic colitis, infectious colitis, or clinical/histologic findings suggestive of UC
* Participants with colonic dysplasia or neoplasia. (Participants with prior history of adenomatous polyps will be eligible if the polyps have been completely removed)
* Participants with past medical history or presence of toxic megacolon
* Participants with presence of enterovesical (ie, between the bowel and urinary bladder) or enterovaginal fistulae
* Participants with current symptomatic diverticulitis or diverticulosis
* Participants with clinically significant obstructive colonic stricture, or who have a history of bowel surgery within 6 months before screening, or who are likely to require surgery for CD during the treatment period. Participants who have undergone previous colonic resection or ileocolectomy more than 6 months before screening must have at least 25 cm of colon remaining
* Participants with past medical history of multiple small bowel resections resulting in clinically significant short bowel syndrome
* Participants requiring total parenteral nutrition
* Participants with past medical history of bowel surgery resulting in an existing or current stoma. Participants who had a j-pouch are excluded as a j-pouch could result in a stoma
* Participants have had prior treatment with ontamalimab (formerly PF-00547659; SHP647)
* Participants with known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds, or any of the stated ingredients
* Participants have received any nonbiologic treatment with immunomodulatory properties (other than AZA, 6-MP, or MTX) or continuous antibiotics (\>2 weeks) for the treatment of CD within 30 days before baseline (Visit 2)
* Participants have received anti-TNF treatment within 60 days before baseline (Visit 2)
* Participants have received any biologic with immunomodulatory properties (other than anti-TNFs) within 90 days before baseline (Visit 2)
* Participants have ever received anti-integrin/adhesion molecule treatment (eg, natalizumab,vedolizumab, efalizumab, etrolizumab, or any other investigational anti-integrin/adhesion molecule)
* Participants have received lymphocytes apheresis or selective monocyte granulocytes apheresis within 60 days before baseline (Visit 2)
* Participants have received enteral nutrition treatment within 30 days before baseline (Visit 2)
* Participants have received parenteral or rectal glucocorticoids or rectal 5-ASA within 14 days before screening colonoscopy
* Participants have taken \>20 milligram per day(mg/day) of prednisone, \>9 mg/day of budesonide, or equivalent oral systemic corticosteroid dose within 14 days before baseline (Visit 2) or have taken \>=40 mg/day of prednisone or equivalent oral systemic corticosteroid dose within 6 weeks before baseline (Visit 2)
* Participants have participated in other investigational studies within either 30 days or 5 half-lives of investigational product used in the study (whichever is longer) before screening (Visit 1)
* Participants have received a live (attenuated) vaccine within 30 days before the baseline visit (Visit 2)
* Participants with active enteric infections (positive stool culture and sensitivity), Clostridium difficile infection or pseudomembranous colitis (subjects with C. difficile infection at screening may be allowed retest after treatment), evidence of active cytomegalovirus infection or Listeria monocytogenes, known active invasive fungal infections such as histoplasmosis or parasitic infections, clinically significant underlying disease that could predispose the subjects to infections, or a history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit (Visit 2)
* Participants with abnormal chest x-ray or other imaging findings at screening (Visit 1), such as presence of active tuberculosis (TB), general infections, heart failure, or malignancy (A chest x-ray, computed tomography scan, etc, performed up to 12 weeks before study entry \[screening, Visit 1\] may be used if available; documentation of the official reading must be located and available in the source documentation)
* Participants with evidence of active or latent infection with Mycobacterium tuberculosis (TB) or participants with this history who have not completed a generally accepted full course of treatment before baseline (Visit 2) are excluded all other participants must have either the Mantoux (purified protein derivative \[PPD\]) tuberculin skin test or interferon-gamma release assay (IGRA) performed

Participants who have no history of previously diagnosed active or latent TB are excluded if they have a positive Mantoux (PPD) tuberculin skin test (ie \>= 5 millimeter \[mm\] induration) or a positive IGRA (the latter to be tested at the site's local laboratory) during screening or within 12 weeks before screening If the IGRA cannot be performed locally, a central laboratory may be used, with prior agreement from the sponsor:

1. An IGRA is strongly recommended for participants with a prior Bacillus Calmette-Guérin vaccination but may be used for any participant Documentation of IGRA product used and the test result must be in the participant's source documentation if performed locally Acceptable IGRA products include QuantiFERON-TB Gold Plus In-Tube Test
2. If the results of the IGRA are indeterminate, the test may be repeated, and if a negative result is obtained, enrollment may proceed In participants with no history of treated active or latent TB, a positive test on repeat will exclude the participantParticipants with a history of active or latent TB infection must follow instructions for "Participants with a prior diagnosis of active or latent TB are excluded unless both of the following criteria are met" in this criterion
3. Participants with repeat indeterminate IGRA results, with no prior TB history, may be enrolled after consultation with a pulmonary or infectious disease specialist who determines low risk of infection (ie, participant would be acceptable for immunosuppressant \[eg, anti-TNF\] treatment without additional action) This consultation must be included in source documentation Results from a chest x-ray, taken within the 12 weeks before or during screening (Visit 1)must show no abnormalities suggestive of active TB infection as determined by a qualified medical specialist

   * Participants with a pre-existing demyelinating disorder such as multiple sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening
   * Participants with any unexplained symptoms suggestive of PML based on the targeted neurological assessment during the screening period
   * Participants with a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed
   * Participants with a significant concurrent medical condition at the time of screening (Visit 1) or baseline (Visit 2), including, but not limited to, the following:

a. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, GI \[except disease under study\], endocrine, cardiovascular, pulmonary, immunologic \[eg, Felty's syndrome\], or local active infection/infectious illness) that, in the investigator's judgment will substantially increase the risk to the subject if he or she participates in the study b. Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence) c. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening (Visit 1) d. History of significant cerebrovascular disease within 24 weeks before screening (Visit 1)

* Participants who have had significant trauma or major surgery within 4 weeks before the screening (Visit 1), or with any major elective surgery scheduled to occur during the study.
* Participant with evidence of cirrhosis with or without decompensation (ie, esophageal varices, hepatic encephalopathy, portal hypertension, ascites)
* Participant with primary sclerosing cholangitis
* Participant with evidence of positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) Note: if a subject tests negative for HBsAg, but positive for HBcAb, the subject would be considered eligible if no presence of hepatitis B virus (HBV) DNA is confirmed by HBV DNA polymerase chain reaction (PCR) reflex testing performed in the central laboratory
* Participant with chronic hepatitis C virus (HCV) (positive HCV antibody \[HCVAb\] and HCV RNA) Note: Participant who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \[defined as no evidence of HCV RNA at least 12 weeks prior to baseline\])
* Participant with any of the following abnormalities in hematology and/or serum chemistry profiles during screening (Visit 1) Note: Screening laboratory tests, if the results are considered by the investigator to be transient and inconsistent with the subject's clinical condition, may be repeated once during the screening period for confirmation results must be reviewed for eligibility prior to the screening colonoscopy procedure

  1. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels \>=3.0 × the upper limit of normal (ULN)
  2. Total bilirubin level \>=1.5 × ULN or \>2.0 × ULN if the subject has a known documented history of Gilbert's syndrome
  3. Hemoglobin level less than or equal to(\<=80) gram per liter(g/L) (8.0 g/deciliter\[dL\])
  4. Platelet count \<=100× 10\^9/L (100,000 cells/mm\^3) or \>=1000 × 10\^9/L (1,000,000 cells/mm\^3)\*
  5. White blood cell count \<=3.5 × 10\^9/L (3500 cells/mm\^3)
  6. Absolute neutrophil count \<2 × 10\^9/L (2000 cells/mm\^3)
  7. Serum creatinine level \>1.5 × ULN or estimated glomerular filtration rate \<30 millilter per minute (mL/min)/173 meter square (m\^2) based on the abbreviated Modification of Diet in RenalDisease Study Equation Note: if platelet count is \<150,000 cells/mm3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified
* Participant with known human immunodeficiency virus (HIV) infection based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory Note: A documented negative HIV test within 6 months of screening is acceptable and does not need to be repeated
* With known human immunodeficiency virus (HIV) infection based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site's local laboratory in accordance with country requirements or tested at the central laboratory.
* Participants who have, or who have a history of (within 2 years before screening), serious psychiatric disease, alcohol dependency, or substance/drug abuse or dependency of any kind including abuse of medicinal marijuana (cannabis)

NOTE: The above Inclusion/Exclusion criteria are NOT exhaustive and other Inclusion/ Exclusion criteria as defined in the protocol may apply.

Primary outcomes:
measure: Number of Participants With Clinical Remission Based on 2-item Patient-reported Outcome (PRO) at Week 16
timeFrame: At Week 16
measure: Number of Participants With Endoscopic Response at Week 16
timeFrame: At Week 16
Secondary outcomes:
measure: Number of Participants With Clinical Remission Based on Crohn's Disease Activity Index (CDAI) Score at Week 16
timeFrame: At Week 16
measure: Number of Participants With Enhanced Endoscopic Response at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Remission Based on 2-item PRO With 4-point Scale for Abdominal Pain at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Response Based on 2-item PRO With 2 Criteria at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Remission Based on 2-Item PRO With Endoscopic Response at Week 16
timeFrame: At Week 16
measure: Number of Participants With Complete Endoscopic Healing at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Response as Measured by CDAI-100 at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Response as Measured by CDAI-70 at Week 16
timeFrame: At Week 16
measure: Number of Participants With Clinical Remission Over Time
timeFrame: At Week 16
measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily Electronic Diary (E-diary) Entries
timeFrame: Baseline and at Week 16
measure: Number of Participants With Endoscopic Healing at Week 16
timeFrame: At Week 16
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Score at Weeks 8, 12 and 16
timeFrame: Baseline, Weeks 8, 12 and 16
measure: Change From Baseline in Short Form-36 Health Survey (SF-36) Scores at Week 16
timeFrame: Baseline, Week 16
measure: Number of Participants Based on Incidence of All-cause Hospitalizations
timeFrame: Baseline up to Week 32
measure: Number of Participants Based on Total Inpatient Days
timeFrame: Baseline up to Week 32
measure: Number of Participants Based on Incidence of CD-related Surgeries and Other Surgical Procedures
timeFrame: Baseline up to Week 32
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Arizona Digestive Health Mesa - East
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies - Phoenix - Clinedge - PPDS
state: Arizona
city: Anaheim
country: United States
facility: Advanced Research Center
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Poway
country: United States
facility: Alliance Clinical Research-(Vestavia Hills)
state: California
city: San Pablo
country: United States
facility: Care Access Research, San Pablo
state: California
city: Cape Coral
country: United States
facility: Renaissance Research Medical Group, INC
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Coral Springs
country: United States
facility: Alliance Medical Research LLC
state: Florida
city: Kissimmee
country: United States
facility: SIH Research
state: Florida
city: Miami Lakes
country: United States
facility: Crystal Biomedical Research
state: Florida
city: Miami
country: United States
facility: Hi Tech and Global Research, LLc
state: Florida
city: Miami
country: United States
facility: Sanchez Clinical Research, Inc
state: Florida
city: Naples
country: United States
facility: Pharma Research International Inc
state: Florida
city: New Port Richey
country: United States
facility: Bayside Clinical Research - New Port Richey
state: Florida
city: Pinellas Park
country: United States
facility: Accel Research Sites - St. Petersburg - ERN - PPDS
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Atlanta
country: United States
facility: Infinite Clinical Trials
state: Georgia
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology PC
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialists, PC
state: Georgia
city: Chicago
country: United States
facility: Loretto Hospital
state: Illinois
city: Gurnee
country: United States
facility: IL Gastroenterology Group
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center
state: Kansas
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Houma
country: United States
facility: CroNOLA, LLC.
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - ClinEdge - PPDS
state: Louisiana
city: Brockton
country: United States
facility: Commonwealth Clinical Studies LLC
state: Massachusetts
city: Winchester
country: United States
facility: Winchester Gastroenterology Associates
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan
state: Michigan
city: Hamtramck
country: United States
facility: National Clinical, LLC
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC
state: Michigan
city: Duluth
country: United States
facility: Mayo Clinic Health System - PPDS
state: Minnesota
city: Plymouth
country: United States
facility: Minnesota Gastroenterology PA
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: North Las Vegas
country: United States
facility: Encompass Care
state: Nevada
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Orchard Park
country: United States
facility: Southtowns Gastroenterology, PLLC
state: New York
city: State College
country: United States
facility: Penn State Hershey Medical Group
state: Pennsylvania
city: Garland
country: United States
facility: Digestive Health Associates of Texas, P.A.dba DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Precision Research Institute, LLC
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Inc.
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute LLC
state: Texas
city: Galax
country: United States
facility: Mid Atlantic Health Specialists
state: Virginia
city: Buenos Aires
country: Argentina
facility: Fundación Favaloro
city: Córdoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Kortrijk
country: Belgium
facility: AZ Groeninge
state: West-Vlaanderen
city: Mouscron
country: Belgium
facility: CHU Mouscron
city: Banja Luka
country: Bosnia and Herzegovina
facility: Clinical Center Banja Luka
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD
state: Sofia-Grad
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Eurohospital
city: Sofia
country: Bulgaria
facility: Second Multiprofile Hospital for Active Treatment Sofia
city: Sofia
country: Bulgaria
facility: Diagnostic and Consulting Center Aleksandrovska EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD - PPDS
city: Sofia
country: Bulgaria
facility: Medical Center Convex EOOD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Centre Mladost - M OOD
city: Cali
country: Colombia
facility: Fundación Valle Del Lili
state: Valle Del Cauca
city: Cali
country: Colombia
facility: IPS Centro Médico Julián Coronel S.A.S. - PPDS
state: Valle Del Cauca
city: Parnu
country: Estonia
facility: OÜ LV Venter
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Athens
country: Greece
facility: Ippokrateio General Hospital of Athens
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Paliao Faliro
country: Greece
facility: Iatriko Palaiou Falirou
city: Patras
country: Greece
facility: University General Hospital of Patras
city: Thessaloniki
country: Greece
facility: Euromedica - PPDS
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Budapest
country: Hungary
facility: ENDOMEDIX Kft.
city: Békéscsaba
country: Hungary
facility: Bekes Megyei Kozponti Korhaz
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Mohacs
country: Hungary
facility: Mohacsi Korhaz
city: Szekszard
country: Hungary
facility: Tolna Megyei Balassa János Kórház
city: Székesfehérvár
country: Hungary
facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaidô
city: Kobe-shi
country: Japan
facility: Medical Corporation Aoyama Clinic
state: Hyôgo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine
state: Hyôgo
city: Asahikawa
country: Japan
facility: Kunimoto Hospital
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: Chiinkai Dojima General & Gastroenterology Clinic
city: Osaka
country: Japan
facility: Yodogawa Christian Hospital
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
city: Tokyo
country: Japan
facility: Nihonbashi Egawa Clinic
city: Oita-city
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
state: Ôita
city: Seongnam
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggido
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggido
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Wonju-si, Gangwon-do
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Beirut
country: Lebanon
facility: Al Zahraa University Hospital
city: Saida
country: Lebanon
facility: Hammoud Hospital University Medical Center
city: Ciudad de Mexico
country: Mexico
facility: Health Pharma Professional Research S.A de C.V.
state: Distrito Federal
city: Zapopan
country: Mexico
facility: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Clinica de Higado y Gastroenterologia Integral, S.C.
state: Morelos
city: Cuernavaca
country: Mexico
facility: JM Research S.C
state: Morelos
city: Monterrey
country: Mexico
facility: Accelerium, S. de R.L. de C.V.
state: Nuevo León
city: Merida
country: Mexico
facility: Unidad de Atencion Medica e Investigacion en Salud
state: Yucatán
city: Distrito Federal
country: Mexico
facility: Centro de Investigacion Clinica Acelerada, S.C.
city: Durango
country: Mexico
facility: Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
state: South Island
city: Newtown
country: New Zealand
facility: Wellington Hospital
state: Wellington
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Lisbon
country: Portugal
facility: Hospital da Luz
state: Lisboa
city: Guimarães
country: Portugal
facility: Hospital Senhora da Oliveira - Guimaraes, E.P.E
city: Portimão
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Nitra
country: Slovakia
facility: KM Management, spol. s r.o.
city: Presov
country: Slovakia
facility: Gastro LM, s.r.o.
city: Cordoba
country: Spain
facility: C.H. Regional Reina Sofia - PPDS
state: Córdoba
city: Madrid
country: Spain
facility: Hospital Universitario La Paz - PPDS
state: Madrid, Communidad Delaware
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Vigo
country: Spain
facility: CHUVI - H.U. Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Centro Medico Teknon - Grupo Quironsalud
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio - PPDS
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital"
state: Chernivets'ka Oblast
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council
state: Kharkivs'ka Oblast
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital
state: Kyïv
city: Dnipro
country: Ukraine
facility: LLC Medical Center Family Medicine Clinic
city: Kharkiv
country: Ukraine
facility: Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
city: Kherson
country: Ukraine
facility: Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Clinic Blagomed
city: Kyiv
country: Ukraine
facility: Medical Center OK!Clinic+LLC International Institute of Clinical Research
city: Kyiv
country: Ukraine
facility: Medical Center of LLC Medical Center Dopomoga-Plus
city: Kyiv
country: Ukraine
facility: Communal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Hospital
city: Lviv
country: Ukraine
facility: Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital
city: Vinnytsia
country: Ukraine
facility: Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital No1"
city: Zaporizhzhia
country: Ukraine
facility: MNPE City Hospital No. 6 of Zaporizhzhia City Council
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: