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GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01434498
First received: September 9, 2011
Last updated: January 12, 2012
Last verified: December 2011
History of Changes
  Purpose

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.


Condition Intervention Phase
Chronic Genotype 1a or 1b HCV Infection
 Drug: GS-5885 tablet
Drug: GS-9451 tablet
Drug: tegobuvir capsule
Drug: ribavirin tablet
Drug: placebo matching ribavirin tablet
Device: placebo matching tegobuvir capsule
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Through 24 weeks of off-treatment follow-up ] [ Designated as safety issue: Yes ]
    To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.

  • Antiviral Activity [ Time Frame: Through 24 weeks of off-treatment follow-up ] [ Designated as safety issue: No ]
    To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.


Secondary Outcome Measures:
  • Viral Dynamics [ Time Frame: Through 10 days of therapy ] [ Designated as safety issue: No ]
    To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.

  • Composite (or Profile) of Pharmacokinetics [ Time Frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose ] [ Designated as safety issue: No ]
    To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½


Estimated Enrollment: 150
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
 Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Drug: tegobuvir capsule
tegobuvir capsule, 30 mg BID
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Active Comparator: Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
 Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Drug: tegobuvir capsule
tegobuvir capsule, 30 mg BID
Drug: placebo matching ribavirin tablet
placebo matching ribavirin tablet, BID
Active Comparator: Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
 Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Device: placebo matching tegobuvir capsule
placebo matching tegobuvir capsule, BID

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult subjects 18 and older with chronic HCV infection
  • Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
  • Monoinfection with HCV genotype 1a or 1b
  • Interferon ineligible or intolerant
  • Body mass index (BMI) between 18 and 40 kg/m2
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Screening laboratory values within defined thresholds
  • Has not been exposed to any investigational drug or device within 30 days of the Screening visit
  • Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

  • Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
  • Decompensated liver disease or cirrhosis
  • Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
  • History of difficulty with blood collection and/or poor venous access
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Suspicion of hepatocellular carcinoma
  • Clinically-relevant drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01434498

  Show 50 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John McNally, PhD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01434498     History of Changes
Other Study ID Numbers: GS-US-248-0132
Study First Received: September 9, 2011
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
Tegobuvir
Treatment naïve
 HCV RNA
Polymerase inhibitor
Protease inhibitor
Interferon intolerant
Interferon ineligible
GS-9190
GS-9451
GS-5885

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Interferons
 Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013