Clinical trial NCT01356160: GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-05-19
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the antiviral efficacy of response guided therapy.
timeFrame: Through 24 weeks post-treatment
Secondary outcomes:
measure: To evaluate the safety and tolerability of each regimen.
timeFrame: Through 24 weeks post-treatment
measure: To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.
timeFrame: Through Day 10 on study
measure: To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.
timeFrame: 12 or 24 weeks
measure: To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.
timeFrame: Through 48 weeks of treatment
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Coronado
country: United States
state: California
city: Costa Mesa
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Burlington
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Forest Hills
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Herston
country: Australia
state: Queensland
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Gilead Sciences
name: Bittoo Kanwar, MD
role: STUDY_CHAIR
References: