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 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
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 13, 2013
CompletedStudy Start
First participant enrolled
February 28, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2014
CompletedDecember 18, 2017
December 1, 2017
1.3 years
February 11, 2013
December 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Safety
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
Week 12
Secondary Outcomes (1)
evidence of HCV RNA viral load reduction
16 weeks
Study Arms (2)
VX-135 low dose in combination with ribavirin
EXPERIMENTAL12 weeks of VX-135 in combination with ribavirin
VX-135 high dose in combination with ribavirin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alios Biopharma Inc.lead
- Vertex Pharmaceuticals Incorporatedcollaborator
Study Sites (1)
Arensia, Republican Clinical Hospital
Chisinau, Moldova
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2013
First Posted
February 13, 2013
Study Start
February 28, 2013
Primary Completion
June 30, 2014
Study Completion
June 30, 2014
Last Updated
December 18, 2017
Record last verified: 2017-12