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

Phase 2

Completed

• Conditions: Chronic Genotype 1a or 1b HCV Infection
• Interventions: Drug: GS-5885 tablet; Drug: GS-9451 tablet; Drug: tegobuvir capsule; Drug: ribavirin tablet; Drug: placebo matching ribavirin tablet; Device: placebo matching tegobuvir capsule

• Registration Number: NCT01434498
• Lead Sponsor: Gilead Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-14
• Study First Posted: 2011-09-15
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-11
• Disposition First Submitted: 2013-11-26
• Disposition First Submitted QC: 2013-11-26
• Last Update Submitted: 2013-11-26
• Disposition First Posted: 2013-12-20
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	ribavirin tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm 1	GS-5885 tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm 1	GS-9451 tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm 1	tegobuvir capsule	GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm 2	GS-5885 tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm 2	GS-9451 tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm 2	tegobuvir capsule	GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm 2	placebo matching ribavirin tablet	GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm 3	GS-5885 tablet	GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Arm 3	GS-9451 tablet	GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Arm 3	ribavirin tablet	GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Arm 3	placebo matching tegobuvir capsule	GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Through 24 weeks of off-treatment follow-up	To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Antiviral Activity	Through 24 weeks of off-treatment follow-up	To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA \< lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.

Secondary Outcome Measures

Name	Time	Method
Composite (or Profile) of Pharmacokinetics	predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose	To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½
Viral Dynamics	Through 10 days of therapy	To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.

Trial Locations

Locations (49)

California Liver Institute; 🇺🇸 Beverly Hills, California, United States

SCTI Research Foundation Liver Center; 🇺🇸 Coronado, California, United States

Scripps Clinic; 🇺🇸 La Jolla, California, United States

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Los Angeles, California, United States

Lightsource Medical; 🇺🇸 Los Angeles, California, United States

Medical Associates Research Group, Inc.; 🇺🇸 San Diego, California, United States

Kaiser Permanente; 🇺🇸 San Diego, California, United States

California Pacific Medical Center; 🇺🇸 San Francisco, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

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