Clinical trial NCT03559517: Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 305)
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 305)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 30
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:

  1. 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
  2. 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)
  3. Presence of acute coronary syndrome (eg, acute myocardial infarction, unstable angina pectoris) within 24 weeks before screening (Visit 1)
  4. 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: Baseline up to Week 16
measure: Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily Electronic Diary (E-diary) Entries at Week 16
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: Tucson
country: United States
facility: CATS Research Center - University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: Atria Clinical Research - Clinedge - PPDS
state: Arkansas
city: Lancaster
country: United States
facility: OM Research LLC - Lancaster - ClinEdge - PPDS
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates PC - CRN - PPDS
state: Colorado
city: Miami
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants LLC - Clinedge - PPDS
state: Florida
city: Saint Augustine
country: United States
facility: East Coast Institute for Research, LLC
state: Florida
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Lake Charles
country: United States
facility: Clinical Trials of SWLA LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center LLC
state: Louisiana
city: Brooklyn
country: United States
facility: New York Total Medical Care PC
state: New York
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Cincinnati
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Fairfield
country: United States
facility: Consultants For Clinical Research Inc
state: Ohio
city: Wyomissing
country: United States
facility: Digestive Disease Associates
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Union City
country: United States
facility: Advanced Gastroenterology-Union City
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research/Coastal Gastroenterology Associates, PA - TDDC - PPDS
state: Texas
city: Cypress
country: United States
facility: Northside Gastroenterology
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research
state: Utah
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Hospital Brisbane
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: St Vincents Hospital Melbourne - PPDS
state: Victoria
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Klinikum Graz
state: Steiermark
city: Vienna
country: Austria
facility: Klinikum Wels-Grieskirchen GmbH
state: Wien
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Wien
country: Austria
facility: Medizinische Universitat Wien (Medical University of Vienna)
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: Grad Zagreb
city: Bjelovar
country: Croatia
facility: Opca bolnica Bjelovar
city: Osijek
country: Croatia
facility: Clinical Hospital Centre Osijek
city: Virovitica
country: Croatia
facility: General Hospital Virovitica
city: Aachen
country: Germany
facility: Universitätsklinikum der RWTH Aachen
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Gastro Campus Research GbR
state: Nordrhein-Westfalen
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitatsklinikum Jena
state: Thüringen
city: Berlin-Zehlendorf
country: Germany
facility: Gastroenterologische Facharztpraxis am Mexikoplatz
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Biberach an der Riss
country: Germany
facility: Sana Klinikum Biberach
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Munich
country: Germany
facility: Klinikum rechts der Isa der Technischen Universitaet Muenchen
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Tiberias
country: Israel
facility: Baruch Padeh Poriya Medical Center
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini Di Catanzaro
state: Calabria
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Di Modena Policlinico
state: Emilia-Romagna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
state: Toscana
city: Negrar
country: Italy
facility: Ospedale Sacro Cuore Don Calabria
state: Veneto
city: Novara
country: Italy
facility: A.O.U. Maggiore della Carità
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
city: Roma
country: Italy
facility: La Sapienza-Università di Roma-Policlinico Umberto I
city: Rozzano (MI)
country: Italy
facility: Istituto Clinico Humanitas
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo Della Sofferenza IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino
city: Sapporo-shi
country: Japan
facility: Sapporo Tokushukai Hospital
state: Hokkaidô
city: Minato-ku
country: Japan
facility: Jikei University Hospital
state: Tokyo
city: Ome
country: Japan
facility: Ome Municipal General Hospital
state: Tokyo
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nishinomiya
country: Japan
facility: Nishinomiya Municipal Central Hospital
city: Onomichi
country: Japan
facility: Onomichi General Hospital
city: Otsu-Shi
country: Japan
facility: Shiga University of Medical Science Hospital
city: Sapporo
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Yokohama
country: Japan
facility: Colo-Proctology Center Matsushima Clinic
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos
city: Vilnius
country: Lithuania
facility: Vilnius City Clinical Hospital
city: Tilburg
country: Netherlands
facility: ETZ-Elisabeth
state: Noord-Brabant
city: Den Helder
country: Netherlands
facility: NWZ, location Alkmaar
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum Amsterdam
city: Wroclaw
country: Poland
facility: Melita Medical
state: Dolnoslaskie
city: Wroclaw
country: Poland
facility: Lexmedica
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Vitamed Galaj i Cichomski sp.j.
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj
state: Kujawsko-pomorskie
city: Wloclawek
country: Poland
facility: Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.
state: Kujawsko-pomorskie
city: Lódz
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny
state: Lódzkie
city: Lódz
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
state: Lódzkie
city: Warszawa
country: Poland
facility: Centrum Medyczne Warszawa - PRATIA - PPDS
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
state: Mazowieckie
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
state: Mazowieckie
city: Warszawa
country: Poland
facility: Miedzyleski Szpital Specjalistyczny w Warszawie
state: Mazowieckie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
state: Podlaskie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Konskie
country: Poland
facility: Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii
state: Swietokrzyskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecińskie Centrum Medyczne
state: Zachodniopomorskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy
city: Czestochowa
country: Poland
facility: Centrum Medyczne Czestochowa - PRATIA - PPDS
city: Gdynia
country: Poland
facility: Centrum Medyczne Gdynia - PRATIA - PPDS
city: Józefów
country: Poland
facility: BioVirtus Centrum Medyczne
city: Katowice
country: Poland
facility: NZOZ All Medicus
city: Lodz
country: Poland
facility: Med Gastr Sp.z.o.o Sp.k
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki
city: Nowa Sól
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Poznan
country: Poland
facility: Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa
city: Rzeszow
country: Poland
facility: Korczowski Bartosz, Gabinet Lekarski
city: Szczecin
country: Poland
facility: Sonomed Sp. z o.o.
city: Warszawa
country: Poland
facility: Centrum Zdrowia M D M
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW
city: Zamosc
country: Poland
facility: Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II
city: Bucharest
country: Romania
facility: Sana Monitoring SRL
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cluj-Napoca Emergency Clinical County Hospital
state: Cluj
city: Bucharest
country: Romania
facility: Dr.Carol Davila Emergency University Central Military Hospital
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Prof. Dr. Matei Bals Institute of Infectious Diseases
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Emergency University Hospital
city: Bucuresti
country: Romania
facility: Centrul Medical Hifu Terramed Conformal S.R.L.
city: Constanta
country: Romania
facility: Affidea Romania SRL
city: Iasi
country: Romania
facility: Gastromedica SRL
city: Oradea
country: Romania
facility: Dr. Tirnaveanu Amelita Private Practice
city: Timisoara
country: Romania
facility: Dr. Goldis Gastroenterology Center SRL
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: Russian Medical Military Academy n.a. S.M. Kirov
city: Samara
country: Russian Federation
facility: Medical University Reaviz
city: Samara
country: Russian Federation
facility: Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city
city: Saratov
country: Russian Federation
facility: SHI Regional Clinical Hospital
city: St. Petersburg
country: Russian Federation
facility: St. Elizabeth Municipal Clinical Hospital
city: Belgrade
country: Serbia
facility: Clinical Hospital Center ''Bezanijska Kosa''
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Vrsac
country: Serbia
facility: General Hospital Vrsac
city: Zemun
country: Serbia
facility: Clinical Hospital Center Zemun
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac
state: Šumadijski Okrug
city: Johannesburg
country: South Africa
facility: CLINRESCO, ARWYP Medical Suites
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr. J Breedt
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Claremont
country: South Africa
facility: Dr JP Wright
state: Western Cape
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
state: Northumberland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary - PPDS
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital - PPDS
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: