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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01356160
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: GS-5885 Drug: GS-9451 Biological: peginterferon alfa-2a Drug: ribavirin tablet Drug: GS-9451 Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
Drug: GS-5885
tablet, 30 mg QD

Drug: 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)

Placebo Comparator: Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
Drug: GS-5885
tablet, 30 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)

Drug: GS-9451 Placebo
Placebo to match GS-9451 QD




Primary Outcome Measures :
  1. To evaluate the antiviral efficacy of response guided therapy. [ Time Frame: Through 24 weeks post-treatment ]
    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.


Secondary Outcome Measures :
  1. To evaluate the safety and tolerability of each regimen. [ Time Frame: Through 24 weeks post-treatment ]
    The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.

  2. To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV. [ Time Frame: Through Day 10 on study ]
    HCV RNA levels, pharmacokinetics and viral sequencing

  3. To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV. [ Time Frame: 12 or 24 weeks ]
    Plasma samples will be collected and stored at each visit for possible resistance analysis.

  4. To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV. [ Time Frame: Through 48 weeks of treatment ]
    Plasma concentrations of the study drug over time will be summarized using descriptive statistics.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356160


Locations
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United States, Arizona
Tucson, Arizona, United States, 85724
United States, California
Beverly Hills, California, United States, 90211
Coronado, California, United States, 92118
Costa Mesa, California, United States, 92626
San Diego, California, United States, 92123
United States, Colorado
Aurora, Colorado, United States, 80045
Englewood, Colorado, United States, 80110
United States, Florida
Bradenton, Florida, United States, 34209
United States, Maryland
Baltimore, Maryland, United States, 21202
Baltimore, Maryland, United States, 21229
United States, Massachusetts
Burlington, Massachusetts, United States, 01805
United States, Missouri
Kansas City, Missouri, United States, 64131
United States, New York
Forest Hills, New York, United States, 11375
Manhasset, New York, United States, 11030
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
Arlington, Texas, United States, 76012
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78215
United States, Virginia
Fairfax, Virginia, United States, 22031
Australia, Queensland
Herston, Queensland, Australia, 4029
Puerto Rico
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Chair: Bittoo Kanwar, MD Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01356160    
Other Study ID Numbers: GS-US-256-0148
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: February 3, 2014
Last Verified: January 2014
Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy HCV RNA
Protease inhibitor
Treatment naïve
GS-5885
GS-9451
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Ledipasvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents