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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01434498
First received: September 9, 2011
Last updated: November 26, 2013
Last verified: November 2013

September 9, 2011
November 26, 2013
September 2011
January 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01434498 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Genotype 1a or 1b HCV Infection
  • 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)
  • Drug: placebo matching ribavirin tablet
    placebo matching ribavirin tablet, BID
  • Device: placebo matching tegobuvir capsule
    placebo matching tegobuvir capsule, BID
  • Active Comparator: Arm 1
    GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
    Interventions:
    • Drug: GS-5885 tablet
    • Drug: GS-9451 tablet
    • Drug: tegobuvir capsule
    • Drug: ribavirin tablet
  • Active Comparator: Arm 2
    GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
    Interventions:
    • Drug: GS-5885 tablet
    • Drug: GS-9451 tablet
    • Drug: tegobuvir capsule
    • Drug: placebo matching ribavirin tablet
  • Active Comparator: Arm 3
    GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
    Interventions:
    • Drug: GS-5885 tablet
    • Drug: GS-9451 tablet
    • Drug: ribavirin tablet
    • Device: placebo matching tegobuvir capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Puerto Rico
 
NCT01434498
GS-US-248-0132
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: John McNally, PhD Gilead Sciences
Gilead Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP