A study with four oral anti-Hepatitis drugs in patients with Hepatitis C who have already had at least one round of treatment.

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002748-28-DE

Enrollment

170

Registered

2011-08-23

Start date

2011-11-30

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection MedDRA version: 14.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Code: GS-5885 Pharmaceutical Form: Film-coated tablet Current Sponsor code: GS-5885 Other descriptive name: GS-5885 Concentration unit: mg milligram(s) Concentration type: equal Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male or female, age = 18 years 3. Confirmation of chronic HCV infection 4. Subjects must have a liver biopsy performed = 3 years prior to screening indicating the absence of cirrhosis 5. Monoinfection with HCV GT 1a or 1b 6. HCV RNA = 104 IU/mL at screening 7. Prior treatment and adherence with one course of pegylated interferon alfa and RBV Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Discontinuation of prior treatment with pegylated interferon alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up 2. Prior treatment of HCV with any direct-acting antiviral or other interferons (whether approved or experimental) 3. Pregnant or nursing female or male with pregnant female partner 4. History of significant cardiac disease 5. Presence of autoimmune disorders 6. Known cirrhosis 7. Chronic liver disease of a non-HCV etiology 8. Poorly-controlled diabetes mellitus 9. Untreated or significant psychiatric illnesses 10. Severe chronic obstructive pulmonary disease

Design outcomes

Primary

Measure	Time frame
Main Objective: • To evaluate the antiviral efficacy as measured by SVR of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection • To evaluate the safety and tolerability of each regimen in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection;Secondary Objective: • To evaluate the antiviral efficacy of each regimen as measured by the proportion of subjects with HCV RNA < LLoQ at Weeks 1, 2, 4, 12 and 24, and with viral breakthrough and relapse • To evaluate the antiviral efficacy (as defined by SVR) of rescue therapy with GS-5885 + GS-9451 + PEG +RBV in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy • To evaluate the emergence of viral resistance to GS-5885, GS-9451, and tegobuvir when administered as part of a combination regimen • To characterize viral dynamics and steady state pharmacokinetics of study drugs in each regimen;Primary end point(s): The primary efficacy endpoint is SVR (HCV RNA < LLoQ 24 weeks post treatment) in all subjects who are randomized and treated.;Timepoint(s) of evaluation of this end point: 24 weeks post treatment.	—

Measure

Time frame

Main Objective: • To evaluate the antiviral efficacy as measured by SVR of combination therapy with GS-5885, GS-9451, tegobuvir and RBV compared with GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and RBV in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection • To evaluate the safety and tolerability of each regimen in treatment-experienced subjects with chronic genotype 1a or 1b HCV infection;Secondary Objective: • To evaluate the antiviral efficacy of each regimen as measured by the proportion of subjects with HCV RNA < LLoQ at Weeks 1, 2, 4, 12 and 24, and with viral breakthrough and relapse • To evaluate the antiviral efficacy (as defined by SVR) of rescue therapy with GS-5885 + GS-9451 + PEG +RBV in subjects who experience viral breakthrough or relapse and enter the Rescue Therapy Substudy • To evaluate the emergence of viral resistance to GS-5885, GS-9451, and tegobuvir when administered as part of a combination regimen • To characterize viral dynamics and steady state pharmacokinetics of study drugs in each regimen;Primary end point(s): The primary efficacy endpoint is SVR (HCV RNA < LLoQ 24 weeks post treatment) in all subjects who are randomized and treated.;Timepoint(s) of evaluation of this end point: 24 weeks post treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints include the proportion of subjects with: HCV RNA < LLoQ at Weeks 1, 2, 4, 12 and 24; viral breakthrough; and relapse.;Timepoint(s) of evaluation of this end point: Weeks 1, 2, 4, 12 and 24 of treatment.	—

Countries

Germany, United States

Contacts

Public ContactMedical Monitor

Gilead Sciences Inc.

clinical.trials@gilead.com+1650574 3000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026