Trial record 1 of 1 for:    GS-US-248-0132
Previous Study | Return to List | Next Study

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
  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:


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


Enrollment: 163
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
GS-9190
GS-9451
GS-5885
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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Ribavirin
Interferons
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 16, 2014