A study to evaluate how different combinations of antiviral agents, when given with standard medicines, affect the treatment outcome of patients infected with the Hepatitis C Virus (HCV).

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000456-42-GB

Enrollment

300

Registered

2011-05-27

Start date

2011-08-11

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Genotype 1 Hepatitis C Virus Infection MedDRA version: 13.1 Level: SOC Classification code 10021881 Term: Infections and infestations System Organ Class: 10021881 - Infections and infestations MedDRA version: 13.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: GS-5885 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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Willing and able to provide written informed consent 2. Male or female, aged from 18 to 70 years old 3. Chronic HCV infection 5. Monoinfection with HCV GT 1 6. HCV RNA > 10e4 IU/mL 7. HCV treatment naïve 8. Candidate for PEG/RBV therapy. 9. Body mass index (BMI) between 18 and 36 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 270 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Pregnant female or male with pregnant female partner 2. Poorly-controlled diabetes mellitus 3. History of clinically significant hemoglobinopathy 4. History of clinically significant retinal disease 5. History of invasive malignancy diagnosed or treated within 5 years 6. Untreated or significant psychiatric illnesses 7. Contraindications for PEG or RBV therapy 8. Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) 9. Chronic use of systemically administered immunosuppressive agents 10. Presence of autoimmune disorders 11. Severe chronic obstructive pulmonary disease 12. History of significant cardiac disease 13. Known cirrhosis 14. Chronic liver disease of a non-HCV etiology 15. History of solid organ transplantation 16. Suspicion of hepatocellular carcinoma 17. Current or prior history of clinical hepatic decompensation

Design outcomes

Primary

Measure	Time frame
Secondary Objective: To evaluate the safety and tolerability of each regimen To characterize viral dynamics and steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV;Main Objective: To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < LLoQ at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV or GS-5885 + PEG/RBV.;Primary end point(s): Plasma HCV RNA <LLoQ;Timepoint(s) of evaluation of this end point: 24 weeks post treatment	—

Measure

Time frame

Secondary Objective: To evaluate the safety and tolerability of each regimen To characterize viral dynamics and steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV;Main Objective: To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < LLoQ at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV or GS-5885 + PEG/RBV.;Primary end point(s): Plasma HCV RNA <LLoQ;Timepoint(s) of evaluation of this end point: 24 weeks post treatment

—

Secondary

Measure	Time frame
Secondary end point(s): vRVR, eRVR, pEVR, HCV RNA < LLoQ;Timepoint(s) of evaluation of this end point: Week 2, 4, 8, 12, 16, 20, 24, 36, 48 of treatment, and at Week 4, 12 and 24 post-treatment.	—

Countries

Australia, Bulgaria, Czech Republic, Germany, Hungary, Italy, New Zealand, United Kingdom, 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