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Completed

NCT Number: NCT01790100

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

The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.

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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

Arensia, Republican Clinical Hospital

Chisinau, Moldova

About this study

Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.

Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.

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 18-60 years of age
  • Subjects must have Chronic Hepatitis C
  • Subjects must be treatment naive
  • 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
  • Diagnosis of or suspected hepatocellular carcinoma

Treatment and study plan

VX-135

Drug

12 weeks of VX-135

Ribavirin

Drug

12 weeks of ribavirin

Primary outcomes

  1. Safety

    Time frame: Week 12

    The safety and tolerability as assessed by evaluating adverse events and laboratory testing.

Secondary outcomes

  1. evidence of HCV RNA viral load reduction

    Time frame: 16 weeks

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

Sponsors and collaborators

Lead sponsor

Alios Biopharma Inc.

Industry

Collaborators

  • Vertex Pharmaceuticals Incorporated

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 13, 2013
Registry last updated
Dec 18, 2017

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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