Clinical trial NCT04583423: A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
Official title: A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis
Keywords: Non-alcoholic fatty liver disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Has histological confirmation of NASH
* Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
* Has a body mass index (BMI) ≥25 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
* Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Contraceptive use by male participants should be consistent with local regulations.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.

Exclusion Criteria

* Has presence of cirrhosis on liver biopsy
* Has Type 1 diabetes
* Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Has a history of bariatric surgery ≤5 years before study participation
* Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
* Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
* Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation

Primary outcomes:
measure: Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks
timeFrame: Week 52
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to 64 weeks
measure: Percentage of Participants Discontinuing Study Medication Due to an AE
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks
timeFrame: Baseline and Week 24
measure: Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks
timeFrame: Week 52
measure: Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks
timeFrame: Week 52
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Adobe Clinical Research, LLC ( Site 2644)
state: Arizona
city: Tucson
country: United States
facility: Arizona Liver Health ( Site 9026)
state: Arizona
city: Tucson
country: United States
facility: Del Sol Research Management ( Site 2674)
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology - North Little Rock ( Site 9015)
state: Arkansas
city: Canoga Park
country: United States
facility: Hope Clinical Research, Inc. ( Site 2601)
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park ( Site 9022)
state: California
city: La Jolla
country: United States
facility: UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group, Inc ( Site 9014)
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake ( Site 9013)
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC ( Site 2643)
state: California
city: Panorama City
country: United States
facility: Velocity Clinical Research, Panorama City ( Site 9001)
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute ( Site 9025)
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research ( Site 9011)
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Santa Ana ( Site 9002)
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates ( Site 2645)
state: Colorado
city: Cutler Bay
country: United States
facility: Top Medical Research, Inc ( Site 2673)
state: Florida
city: Fort Myers
country: United States
facility: Covenant Metabolic Specialists, LLC ( Site 9027)
state: Florida
city: Gainesville
country: United States
facility: North Florida South Georgia Veterans Health System ( Site 2613)
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center Inc ( Site 2610)
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty Inc ( Site 2660)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 2656)
state: Florida
city: Miami Springs
country: United States
facility: Ocean Blue Medical Research Center Inc ( Site 2667)
state: Florida
city: Miami
country: United States
facility: Genoma Research Group, Inc. ( Site 2669)
state: Florida
city: Ocoee
country: United States
facility: Sensible Healthcare Llc ( Site 2607)
state: Florida
city: Orlando
country: United States
facility: Synexus Research ( Site 2672)
state: Florida
city: Dalton
country: United States
facility: Southeast Clinical Research Center ( Site 9003)
state: Georgia
city: Iowa City
country: United States
facility: The University of Iowa ( Site 2655)
state: Iowa
city: Marrero
country: United States
facility: Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)
state: Louisiana
city: Biloxi
country: United States
facility: The National Diabetes & Obesity Research Institute ( Site 9017)
state: Mississippi
city: Kansas City
country: United States
facility: Kansas City Research Institute ( Site 9018)
state: Missouri
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC ( Site 2603)
state: Nevada
city: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse ( Site 9016)
state: New York
city: New York
country: United States
facility: NYU Langone Health, New York ( Site 2627)
state: New York
city: Flourtown
country: United States
facility: Hillmont G.I. ( Site 9019)
state: Pennsylvania
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)
state: Pennsylvania
city: Wyomissing
country: United States
facility: Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)
state: Pennsylvania
city: Clarksville
country: United States
facility: Premier Medical Group ( Site 9010)
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute ( Site 2619)
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center ( Site 2638)
state: Texas
city: Edinburg
country: United States
facility: DHR Health Institute for Research and Development ( Site 9006)
state: Texas
city: Edinburg
country: United States
facility: South Texas Research Institute ( Site 9012)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc. ( Site 2611)
state: Texas
city: San Antonio
country: United States
facility: Quality Research ( Site 9024)
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at Texas Liver Institute ( Site 2634)
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC ( Site 2614)
state: Texas
city: Waco
country: United States
facility: Impact Research Institute ( Site 2685)
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System ( Site 2657)
state: Virginia
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)
state: Buenos Aires
city: Pilar
country: Argentina
facility: Hospital Universitario Austral ( Site 0003)
state: Buenos Aires
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada ( Site 0011)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Británico de Buenos Aires ( Site 0002)
state: Caba
city: Buenos Aires
country: Argentina
facility: Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)
state: Caba
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)
state: Caba
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0007)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 0009)
city: Santa Fe
country: Argentina
facility: Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital ( Site 0102)
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital ( Site 0104)
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre ( Site 0107)
state: South Australia
city: Vancouver
country: Canada
facility: GIRI GI Research Institute - Vancouver ( Site 0404)
state: British Columbia
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital ( Site 0401)
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0400)
state: Quebec
city: Concepcion
country: Chile
facility: Hospital Regional de Concepcion ( Site 0505)
state: Biobio
city: La Serena
country: Chile
facility: Hospital San Juan de Dios de La Serena ( Site 0500)
state: Coquimbo
city: Valdivia
country: Chile
facility: Clinical Research Chile SpA ( Site 0506)
state: Los Rios
city: Santiago
country: Chile
facility: Enroll SpA ( Site 0508)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile ( Site 0501)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)
state: Valparaiso
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University ( Site 0605)
state: Beijing
city: Wanzhou District
country: China
facility: Chongqing Three Gorges Central Hospital ( Site 0618)
state: Chongqing
city: Foshan
country: China
facility: The First People's Hospital of Foshan-Infection Department ( Site 0612)
state: Guangdong
city: Yinchuan City
country: China
facility: General Hospital of Ningxia Medical University ( Site 0607)
state: Ningxia
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)
state: Shanghai
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University ( Site 0600)
state: Zhejiang
city: Bogotá
country: Colombia
facility: Fundacion Santa Fe de Bogota ( Site 0705)
state: Distrito Capital De Bogota
city: Nice
country: France
facility: CHU de Nice Hopital de l Archet II ( Site 0800)
state: Alpes-Maritimes
city: Pessac
country: France
facility: hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)
state: Aquitaine
city: Lyon
country: France
facility: Hopital de la Croix-Rousse ( Site 0809)
state: Auvergne
city: Dijon
country: France
facility: CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)
state: Bourgogne
city: Besançon
country: France
facility: CHU Besançon ( Site 0806)
state: Franche-Comte
city: Limoges
country: France
facility: Centre Hospitalier et Universitaire Dupuytren ( Site 0810)
state: Haute-Vienne
city: Clichy
country: France
facility: Hôpital Beaujon ( Site 0804)
state: Hauts-de-Seine
city: Vandoeuvre les Nancy
country: France
facility: C.H.U. Nancy Hopital de Brabois ( Site 0803)
state: Meurthe-et-Moselle
city: Lille
country: France
facility: Hôpital Claude Huriez ( Site 0811)
state: Nord
city: Creteil
country: France
facility: Hopital Henri Mondor ( Site 0808)
state: Val-de-Marne
city: Paris
country: France
facility: A.P.H. Paris, Hopital Saint Antoine ( Site 0807)
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere ( Site 0813)
city: Paris
country: France
facility: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0446)
state: Baden-Wurttemberg
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)
state: Hessen
city: Mainz
country: Germany
facility: Johannes Gutenberg Universitat Mainz ( Site 0442)
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 0447)
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0443)
city: Thessaloniki
country: Greece
facility: Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)
state: Kentriki Makedonia
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 1003)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 1001)
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital ( Site 1002)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 1201)
city: Haifa
country: Israel
facility: Carmel Medical Center ( Site 1203)
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center ( Site 1205)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1204)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 1200)
city: Ramat Hasharon
country: Israel
facility: Maccabi Health Services - Ramat Hasharon ( Site 1206)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1202)
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)
state: Lombardia
city: Modena
country: Italy
facility: A O U Policlinico di Modena ( Site 1307)
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I ( Site 1300)
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital ( Site 1402)
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1417)
state: Ehime
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital ( Site 1409)
state: Gifu
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)
state: Hokkaido
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital ( Site 1419)
state: Ishikawa
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 1414)
state: Kagawa
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)
state: Kagawa
city: Kawasaki
country: Japan
facility: Shinyurigaoka General Hospital ( Site 1420)
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 1411)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 1407)
state: Nara
city: Suita
country: Japan
facility: Saiseikai Suita Hospital ( Site 1403)
state: Osaka
city: Fukui
country: Japan
facility: Fukui-ken Saiseikai Hospital ( Site 1410)
city: Gifu
country: Japan
facility: Gifu Municipal Hospital ( Site 1408)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 1413)
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital ( Site 1418)
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)
city: Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center ( Site 1412)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 1415)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 1401)
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)
state: Kyonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital-Internal Medicine ( Site 2010)
state: Pusan-Kwangyokshi
city: Dongjak-gu
country: Korea, Republic of
facility: Chungang University Hospital ( Site 2007)
state: Seoul
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 2001)
state: Seoul
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2003)
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital ( Site 2002)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 2004)
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)
city: Mexico City
country: Mexico
facility: Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)
state: Jalisco
city: Zapopan
country: Mexico
facility: Centro de Investigacion Medica de Occidente S.C. ( Site 1514)
state: Jalisco
city: Merida
country: Mexico
facility: Medical Care and Research S.A. de C.V. ( Site 1506)
state: Yucatan
city: Mexico City
country: Mexico
facility: Centro de Investigacion y Gastroenterologia SC ( Site 1503)
city: Christchurch
country: New Zealand
facility: Christchurch Hospital ( Site 1602)
state: Canterbury
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies Limited ( Site 1600)
city: Auckland
country: New Zealand
facility: Middlemore Clinical Trials ( Site 1601)
city: Rio Piedras
country: Puerto Rico
facility: Pan American Center for Oncology Trials ( Site 3102)
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group ( Site 3100)
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research ( Site 3101)
city: Moscow
country: Russian Federation
facility: City Clinical Hospital named V.M.Buyanova ( Site 1922)
state: Moskva
city: Moscow
country: Russian Federation
facility: Russian University of People Friendship ( Site 1907)
state: Moskva
city: Moscow
country: Russian Federation
facility: Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)
state: Moskva
city: Moscow
country: Russian Federation
facility: Center targetnoy therapy-Gastroenterology ( Site 1918)
state: Moskva
city: Moscow
country: Russian Federation
facility: Medical Rehabilitation Center ( Site 1904)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Scientific research center ECO-security ( Site 1920)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: Surgical Clinic "Parada" ( Site 1921)
state: Sankt-Peterburg
city: Saint Petersburg
country: Russian Federation
facility: LLC Astarta ( Site 1912)
state: Sankt-Peterburg
city: St -Petersburg
country: Russian Federation
facility: SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)
state: Sankt-Peterburg
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago ( Site 2104)
state: La Coruna
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)
state: Madrid
city: Sevila
country: Spain
facility: Hospital Universitario Virgen del Rocio ( Site 2105)
state: Sevilla
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 2101)
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona ( Site 2102)
city: Huddinge
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge ( Site 2900)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset ( Site 2901)
state: Uppsala Lan
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital ( Site 2308)
state: Chiayi
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital ( Site 2307)
state: Taichung
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)
state: Taoyuan
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2306)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2304)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2301)
city: Ankara
country: Turkey
facility: Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty ( Site 2405)
city: Ankara
country: Turkey
facility: Ankara University Cebeci Research and Application Hospital ( Site 2406)
city: Istanbul
country: Turkey
facility: Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty ( Site 2404)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director, MD
role: STUDY_DIRECTOR
References: