Clinical trial NCT01434498: GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Genotype 1a or 1b HCV Infection
Keywords: Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Tegobuvir
Treatment naïve
HCV RNA
Polymerase inhibitor
Protease inhibitor
Interferon intolerant
Interferon ineligible
GS-9190
GS-9451
GS-5885
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.


Eligibility criteria: Inclusion Criteria:

* Adult subjects 18 and older with chronic HCV infection
* Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
* Monoinfection with HCV genotype 1a or 1b
* Interferon ineligible or intolerant
* Body mass index (BMI) between 18 and 40 kg/m2
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
* Screening laboratory values within defined thresholds
* Has not been exposed to any investigational drug or device within 30 days of the Screening visit
* Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

* Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
* Decompensated liver disease or cirrhosis
* Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
* History of difficulty with blood collection and/or poor venous access
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Suspicion of hepatocellular carcinoma
* Clinically-relevant drug abuse

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Through 24 weeks of off-treatment follow-up
measure: Antiviral Activity
timeFrame: Through 24 weeks of off-treatment follow-up
Secondary outcomes:
measure: Viral Dynamics
timeFrame: Through 10 days of therapy
measure: Composite (or Profile) of Pharmacokinetics
timeFrame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: California Liver Institute
state: California
city: Coronado
country: United States
facility: SCTI Research Foundation Liver Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Medical Center
state: California
city: Los Angeles
country: United States
facility: Lightsource Medical
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group, Inc.
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Miami
country: United States
facility: University of Miami, Center for Liver Diseases
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center (ACH)
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Newark
country: United States
facility: Saint Michael's Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, P.A.
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: The North Texas Research Institute
state: Texas
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Sciences Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Falls Church
country: United States
facility: Inova Fairfax Hospital Center for Liver Diseases
state: Virginia
city: Newport News
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University Of Alberta Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Care Centre
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI GI Research Institute
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Saint-Luc DU CHUM
state: Quebec
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico Inc
Study officials:
affiliation: Gilead Sciences
name: John McNally, PhD
role: STUDY_DIRECTOR
References: