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GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01384383
First received: June 22, 2011
Last updated: August 22, 2012
Last verified: February 2012
History of Changes
  Purpose

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.


Condition Intervention Phase
Chronic Hepatitis C
 Drug: GS-5885, GS-9451, PEG , RBV
Drug: PEG, RBV
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Sustained virologic response (SVR) [ Time Frame: 30 , 36 or 48 weeks ] [ Designated as safety issue: No ]
    Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.


Secondary Outcome Measures:
  • Safety and tolerability of therapy. [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.

  • Virologic response [ Time Frame: Weeks 2, 4, 6, 8, 10, and 12 ] [ Designated as safety issue: No ]
    Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse

  • Compare SVR [ Time Frame: Weeks 30 and 36 ] [ Designated as safety issue: No ]
    Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.

  • Viral resistance [ Time Frame: Up to 96 Weeks ] [ Designated as safety issue: No ]
    Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV


Estimated Enrollment: 235
Study Start Date: August 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Response-Guided Therapy (RGT)with GS-5885 30 mg QD + GS-9451 200 mg QD + Peginterferon Alfa 2a (PEG)/Ribavirin (RBV) for 6 or 12 weeks of treatment.
 Drug: GS-5885, GS-9451, PEG , RBV
GS-5885 tablet 30 mg QD, GS-9451 tablet 200 mg QD, Peginterferon Alfa 2a (PEG)180 ug/week(solution for injection), Ribavirin (RBV)tablet (weight based: 1000mg/day < 75 kg ; 1200mg/day => 75kg divided twice daily [BID])
Experimental: Arm 2
Response-Guided Therapy (RGT) with Peginterferon Alfa 2a (PEG)/Ribavirin (RBV) for 24 weeks of treatment
 Drug: PEG, RBV
Peginterferon Alfa 2a (PEG) 180 ug/week(solution for injection), Ribavirin (RBV) tablet (weight based: 1000mg/day < 75 kg ; 1200mg/day => 75kg divided twice daily [BID])

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18-70 years of age
  • Chronic HCV infection
  • Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months of Screening in countries where allowed
  • Monoinfection with HCV genotype 1a or 1b
  • HCV RNA > 10^4 IU/mL at Screening
  • IL28B CC genotype
  • HCV treatment naïve
  • Candidate for PEG/RBV therapy
  • Body mass index (BMI) between 18 and 36 kg/m2
  • Creatinine clearance >= 50 mL/min
  • Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline

Exclusion Criteria:

  • Exceed defined thresholds for key laboratory parameters at Screening
  • 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 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. Subjects on stable methadone maintenance treatment for at least 6 months prior to Screening may be included into the study
  • Use of prohibited concomitant medications two weeks prior to baseline through the end of treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384383

  Show 60 Study Locations
Sponsors and Collaborators
Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01384383     History of Changes
Other Study ID Numbers: GS-US-248-0121
Study First Received: June 22, 2011
Last Updated: August 22, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Chronic Hepatitis C
IL28B CC Genotype
Treatment naive
Peginterferon α-2a (PEG)
Genotype 1a/b
 GS 9451
GS 5885
Ribavirin (RBV)
HCV NS5A inhibitor
HCV NS3 protease inhibitor

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013