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

NCT01356160 | Completed Phase 2

• 1 other identifier: GS-US-256-0148
• Study Type: interventional
• Target: 351
• Locations: 3 countries
• Sites: 23

Brief 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.

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy HCV RNA; Protease inhibitor; Treatment naïve; GS-5885; GS-9451

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• To evaluate the safety and tolerability of each regimen.

  Through 24 weeks post-treatment

• To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.

  Through Day 10 on study

• To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.

  12 or 24 weeks

• To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.

  Through 48 weeks of treatment

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV

Drug: GS-5885; Drug: GS-9451; Biological: peginterferon alfa-2a; Drug: ribavirin tablet

Arm 2

PLACEBO COMPARATOR

RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV

Drug: GS-5885; Biological: peginterferon alfa-2a; Drug: ribavirin tablet; Drug: GS-9451 Placebo

Interventions

GS-5885 DRUG

tablet, 30 mg QD

Arm 1; Arm 2

GS-9451 DRUG

tablet, 200 mg QD

Arm 1

peginterferon alfa-2a BIOLOGICAL

(solution for injection) 180 µg/week

Arm 1; Arm 2

ribavirin tablet DRUG

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

Arm 1; Arm 2

GS-9451 Placebo DRUG

Placebo to match GS-9451 QD

Arm 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (23)

Unknown Facility

Tucson, Arizona, 85724, United States

Location

Unknown Facility

Beverly Hills, California, 90211, United States

Location

Unknown Facility

Coronado, California, 92118, United States

Location

Unknown Facility

Costa Mesa, California, 92626, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Englewood, Colorado, 80110, United States

Location

Unknown Facility

Bradenton, Florida, 34209, United States

Location

Unknown Facility

Baltimore, Maryland, 21202, United States

Location

Unknown Facility

Baltimore, Maryland, 21229, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

Unknown Facility

Kansas City, Missouri, 64131, United States

Location

Unknown Facility

Forest Hills, New York, 11375, United States

Location

Unknown Facility

Manhasset, New York, 11030, United States

Location

Unknown Facility

Durham, North Carolina, 27710, United States

Location

Unknown Facility

Cincinnati, Ohio, 45267, United States

Location

Unknown Facility

Nashville, Tennessee, 37211, United States

Location

Unknown Facility

Arlington, Texas, 76012, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

Unknown Facility

Fairfax, Virginia, 22031, United States

Location

Unknown Facility

Herston, Queensland, 4029, Australia

Location

Unknown Facility

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

ledipasvir; GS-9451; peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Bittoo Kanwar, MD

  Gilead Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 19, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

US (21); AU (1); PR (1)