Study of Oral Treatments for Hepatitis C

PHASE4CompletedINTERVENTIONAL
Enrollment

1,275

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

June 13, 2019

Study Completion Date

September 2, 2020

Conditions
Chronic Hepatitis C
Interventions
DRUG

SOF/LDV (sofosbuvir/ledipasvir)

Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)

DRUG

PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)

Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)

DRUG

EBR/GZR (elbasvir/grazoprevir)

Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks

DRUG

Ribavirin

200 mg pills (1-3 pills, 1-2 times per day)

Trial Locations (38)

10003

Mt. Sinai Beth Israel, New York

10016

New York Langone Medical Center, New York

10021

Weill Cornell Medical College, New York

10032

Columbia University Medical Center, New York

12184

Mountain View Medical Center, Valatie

19104

University of Pennsylvania, Philadelphia

20007

Georgetown University, Washington D.C.

20060

Howard University, Washington D.C.

21093

John Hopkins University, Lutherville

23226

Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia), Richmond

23284

Virginia Commonwealth University, Richmond

27599

University of North Carolina at Chapel Hill, Chapel Hill

27710

Duke University Medical Center, Durham

30312

Internal Medicine Associates of Wellstar Atlanta Medical Center, Atlanta

32209

University of Florida, Jacksonville, Jacksonville

32803

Orlando Immunology Center, Orlando

33136

University of Miami/Schiff Center for Liver Diseases, Miami

39232

GI Associates & Endoscopy Center, Flowood

45267

University of Cincinnati, Cincinnati

46202

Indiana University Medical Center, Indianapolis

48109

University of Michigan, Ann Arbor

55455

University of Minnesota, Minneapolis

60611

Northwestern University, Chicago

60647

Northwestern University, Chicago

63104

Saint Louis University, St Louis

68198

University of Nebraska Medical Ctr, Omaha

72205

Liver Wellness Center, Little Rock

77030

Research Specialist of Texas, Houston

87505

Southwest CARE Center, Santa Fe

92103

UCSD Medical Center, San Diego

94110

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco

94143

Univ of California, San Francisco, San Francisco

94304

Stanford University, Palo Alto

98101

Virginia Mason Medical Center, Seattle

98104

University of Washington, Seattle

06520

Yale University Digestive Diseases, New Haven

32610-0272

University of Florida, Gainesville

02114

Massachusetts General Hospital, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

AbbVie

INDUSTRY

lead

University of Florida

OTHER