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Completed

NCT Number: NCT01516918

A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.

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Key information

Conditions

Chronic Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vancouver, British Columbia, 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

  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must have compensated cirrhosis
  • Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
  • Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion criteria

  • Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
  • Any contraindication to Peg-IFN or RBV therapy
  • Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
  • A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines

Treatment and study plan

VX-222

Drug

tablet, 400-mg twice daily

Telaprevir

Drug

tablet, 1125-mg twice daily

Other names: Incivek, VX-950, Incivo

Ribavirin

Drug

tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily

Other names: Copegus

peginterferon-alfa-2a

Biological

subcutaneous injection, 180-mcg, once weekly

Other names: Pegasys

Primary outcomes

  1. The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)

    Time frame: 12 weeks

Secondary outcomes

  1. The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.

    Time frame: up to 48 weeks

  2. The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)

    Time frame: 24 weeks

  3. The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment

    Time frame: up to week 12

  4. The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment

    Time frame: up to 48 weeks

  5. The association of the IL-28B genotype with SVR12

    Time frame: 12 weeks

    Proportion of subjects who have SVR12 by IL-28B genotype

  6. The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure

    Time frame: After the last planned dose of study drug or after time of failure

    The identity and observed frequency of viral variants as compared to wild-type virus will be measured.

  7. VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Oct 20, 2014

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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