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NCT Number: NCT00758043

A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Male and female subjects, 18 to 70 years of age, inclusive
  • Genotype 1, chronic hepatitis C with detectable HCV RNA.
  • Screening laboratory values, tests, and physical exam within acceptable ranges
  • Able and willing to follow contraception requirements
  • Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion criteria

  • Subject has any contraindications to Pegasys® or Copegus® therapy
  • Evidence of hepatic decompensation in cirrhotic subjects
  • History of organ transplant
  • History of, or any current medical condition which could impact the safety of the subject in participation in the study

Treatment and study plan

Telaprevir

Drug

750 mg every 8 hours (q8h) for 12 weeks

Other names: VX-950

Ribavirin

Drug

1000 - 1200 mg/day based on body weight for either 24 or 48 weeks

Other names: Copegus

peginterferon alfa-2a

Biological

180 mcg/week for either 24 or 48 weeks

Other names: Pegasys

Primary outcomes

  1. Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)

    Time frame: 24 weeks after the last planned dose of study treatment

    SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification [LLOQ] of 25 IU/mL).

Secondary outcomes

  1. Proportion of Subjects Who Have Undetectable HCV RNA at Week 72

    Time frame: 72 weeks after the last planned dose of study treatment

    SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.

  2. Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

    Time frame: Week 4 and Week 12

    Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).

  3. Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment

    Time frame: 12 weeks after last dose of study treatment

    SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.

  4. Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)

    Time frame: Week 24 or Week 48

  5. Proportion of Randomized Subjects Who Relapse

    Time frame: From EOT to Week 48 or Week 72

    Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).

  6. Proportion of Enrolled Subjects Who Relapse

    Time frame: From EOT to Week 48 or Week 72

    Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.

  7. Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Day 1 up to Week 72

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Collaborators

  • Tibotec Pharmaceutical Limited

Registry information

Official study title

A Randomized Study of Stopping Treatment at 24 Weeks or Continuing Treatment to 48 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response While Receiving Telaprevir, Peginterferon Alfa2a (Pegasys®) and Ribavirin (Copegus®)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 23, 2008
Registry last updated
Mar 26, 2021

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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