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

A

Alios Biopharma

Status and phase

Completed
Phase 2

Conditions

Chronic Hepatitis C

Treatments

Drug: Ribavirin
Drug: VX-135

Study type

Interventional

Funder types

Industry

Identifiers

NCT01790100
ALS-135-101
2012-005633-37 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

VX-135 low dose in combination with ribavirin
Experimental group
Description:
12 weeks of VX-135 in combination with ribavirin
Treatment:
Drug: VX-135
Drug: Ribavirin
VX-135 high dose in combination with ribavirin
Experimental group
Treatment:
Drug: VX-135
Drug: Ribavirin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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