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Completed

NCT Number: NCT01434498

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 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.

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Key information

Conditions

Chronic Genotype 1a or 1b HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-5885 tablet

Drug

GS-5885 tablet, 90 mg, QD

GS-9451 tablet

Drug

GS-9451 tablet, 200 mg QD

tegobuvir capsule

Drug

tegobuvir capsule, 30 mg BID

ribavirin tablet

Drug

ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

placebo matching ribavirin tablet

Drug

placebo matching ribavirin tablet, BID

placebo matching tegobuvir capsule

Device

placebo matching tegobuvir capsule, BID

Primary outcomes

  1. Safety and Tolerability

    Time frame: Through 24 weeks of off-treatment follow-up

    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.

  2. Antiviral Activity

    Time frame: Through 24 weeks of off-treatment follow-up

    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 outcomes

  1. Viral Dynamics

    Time frame: Through 10 days of therapy

    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.

  2. Composite (or Profile) of Pharmacokinetics

    Time frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

    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

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2011
Registry last updated
Dec 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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