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NCT Number: NCT01726946

A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C

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Key information

Conditions

Chronic Hepatitis C 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–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California, La Jolla, United States

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Subjects (male and female) must be between the ages of 18 and 60 years at screening
  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must be treatment naïve
  • Subjects must have laboratory values at screening within limits as specified by the protocol

Key Exclusion Criteria:

  • Evidence of cirrhosis
  • Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
  • Any other cause of significant liver disease in addition to hepatitis C
  • Human immunodeficiency virus -1 or -2
  • Diagnosis of or suspected hepatocellular carcinoma
  • History of organ transplant, with the exception of corneal transplants and skin grafts

Treatment and study plan

VX-135

Drug

12 weeks of VX-135

Ribavirin

Drug

12 weeks of ribavirin

Primary outcomes

  1. The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments

    Time frame: Up to 52 weeks

Secondary outcomes

  1. The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)

    Time frame: 16 weeks

  2. The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)

    Time frame: 24 weeks

  3. The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)

    Time frame: 36 weeks

  4. The proportion of subjects who have virologic relapse

    Time frame: Up to 52 weeks

  5. Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA

    Time frame: Up to 64 weeks

  6. The proportion of subjects who have virologic breakthrough

    Time frame: Up to 52 weeks

    as measured by on-treatment HCV RNA values

  7. The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)

    Time frame: up to 28 weeks

  8. The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment

    Time frame: Up to 60 weeks

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 15, 2012
Registry last updated
Apr 16, 2015

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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