Back to resultsA 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
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 2
Locations
Moldova, Republic of
Study Type
Interventional
Intervention
VX-135
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C
Eligibility 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
Sites / Locations
- Arensia, Republican Clinical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VX-135 low dose in combination with ribavirin
VX-135 high dose in combination with ribavirin
Arm Description
12 weeks of VX-135 in combination with ribavirin
Outcomes
Primary Outcome Measures
Safety
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
Secondary Outcome Measures
evidence of HCV RNA viral load reduction
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Full Information
NCT ID
NCT01790100
First Posted
February 11, 2013
Last Updated
December 14, 2017
Sponsor
Alios Biopharma Inc.
Collaborators
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01790100
Brief Title
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
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 28, 2013 (Actual)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
June 30, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alios Biopharma Inc.
Collaborators
Vertex Pharmaceuticals Incorporated
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VX-135 low dose in combination with ribavirin
Arm Type
Experimental
Arm Description
12 weeks of VX-135 in combination with ribavirin
Arm Title
VX-135 high dose in combination with ribavirin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VX-135
Intervention Description
12 weeks of VX-135
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
12 weeks of ribavirin
Primary Outcome Measure Information:
Title
Safety
Description
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
evidence of HCV RNA viral load reduction
Description
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arensia, Republican Clinical Hospital
City
Chisinau
Country
Moldova, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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