- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726946
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
March 27, 2015 updated by: Vertex Pharmaceuticals Incorporated
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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La Jolla, California, United States
- California
-
-
Florida
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Orlando, Florida, United States
- Florida
-
-
Georgia
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Marietta, Georgia, United States
- Georgia
-
-
Tennessee
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Germantown, Tennessee, United States
- Tennessee
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Texas
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Arlington, Texas, United States
- Texas
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Houston, Texas, United States
- Texas
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: VX-135 High Dose with ribavirin
12 weeks of a high dose of VX-135 in combination with ribavirin
|
12 weeks of VX-135
12 weeks of ribavirin
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EXPERIMENTAL: VX-135 Low Dose with ribavirin
12 weeks of a low dose of VX-135 in combination with ribavirin
|
12 weeks of VX-135
12 weeks of ribavirin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time Frame: 16 weeks
|
16 weeks
|
|
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time Frame: 24 weeks
|
24 weeks
|
|
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Time Frame: 36 weeks
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36 weeks
|
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The proportion of subjects who have virologic relapse
Time Frame: Up to 52 weeks
|
Up to 52 weeks
|
|
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
|
Up to 64 weeks
|
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The proportion of subjects who have virologic breakthrough
Time Frame: Up to 52 weeks
|
as measured by on-treatment HCV RNA values
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Up to 52 weeks
|
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time Frame: up to 28 weeks
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up to 28 weeks
|
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The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
February 1, 2014
Study Registration Dates
First Submitted
November 7, 2012
First Submitted That Met QC Criteria
November 9, 2012
First Posted (ESTIMATE)
November 15, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
April 16, 2015
Last Update Submitted That Met QC Criteria
March 27, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- VX12-135-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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