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Completed

NCT Number: NCT01581138

VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C

The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.

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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

Birmingham, Alabama, United States

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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 (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
  • Subjects will be treatment naïve
  • Subjects must have documentation of the presence or absence of cirrhosis

Exclusion criteria

  • History or other clinical evidence of significant or unstable cardiac disease
  • Evidence of hepatic decompensation
  • Diagnosed or suspected hepatocellular carcinoma
  • Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
  • History of organ transplant, with the exception of corneal transplants and skin grafts

Treatment and study plan

VX-222

Drug

400 mg tablets twice daily for oral administration

Telaprevir

Drug

1125 mg tablets twice daily for oral administration

Other names: VX-950, INCIVEK, INCIVO, TELAVIC

Ribavirin

Drug

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

Other names: Copegus

Primary outcomes

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

    Time frame: 12 weeks after the last planned dose of treatment

Secondary outcomes

  1. The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)

    Time frame: up to 20 weeks

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

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

  3. The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug

    Time frame: 4 weeks after the last planned dose of the study drug

  4. The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)

    Time frame: 48 weeks either after the last planned dose of study drug or after time of failure

  5. The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)

    Time frame: up to 16 weeks

  6. Time to achieve <LLOQ undetectable HCV RNA

    Time frame: up to 16 weeks

  7. The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)

    Time frame: up to 16 weeks

  8. The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12

    Time frame: 12 weeks after the last planned dose of treatment

  9. The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure

    Time frame: 48 weeks either after the last planned dose of study drug or after time of failure

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 20, 2012
Registry last updated
Jul 4, 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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