GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356160
• Other study ID #: GS-US-256-0148
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2011
• Last updated: January 2, 2014
• Start date: July 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males and females 18-70 years of age

• Chronic HCV infection

• Subjects must have liver biopsy results (= 2 years prior to Screening) indicating the absence of cirrhosis.

• Monoinfection with HCV genotype 1

• HCV RNA > 10^4 IU/mL at Screening

• HCV treatment naïve

• Candidate for PEG/RBV therapy

• Body mass index (BMI) 18-36 kg/m2, inclusive

• Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.

Exclusion Criteria:

• Pregnant female or male with pregnant female partner

• Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)

• Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.

• Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• GS-5885
tablet, 30 mg QD
• GS-9451
tablet, 200 mg QD

Biological:
• peginterferon alfa-2a
(solution for injection) 180 µg/week

Drug:
• ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day = 75 kg) divided twice daily (BID)
• GS-9451 Placebo
Placebo to match GS-9451 QD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the antiviral efficacy of response guided therapy.	To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.	Through 24 weeks post-treatment	No
Secondary	To evaluate the safety and tolerability of each regimen.	The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.	Through 24 weeks post-treatment	No
Secondary	To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.	HCV RNA levels, pharmacokinetics and viral sequencing	Through Day 10 on study	No
Secondary	To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.	Plasma samples will be collected and stored at each visit for possible resistance analysis.	12 or 24 weeks	No
Secondary	To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.	Plasma concentrations of the study drug over time will be summarized using descriptive statistics.	Through 48 weeks of treatment	No