Back to resultsVX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Primary Purpose
Chronic Hepatitis C Virus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VX-222
telaprevir
ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects will be treatment naïve
- Subjects must have documentation of the presence or absence of cirrhosis
Exclusion Criteria:
- History or other clinical evidence of significant or unstable cardiac disease
- Evidence of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- History of organ transplant, with the exception of corneal transplants and skin grafts
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
12 week treatment
16 week treatment
Arm Description
Outcomes
Primary Outcome Measures
The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
Secondary Outcome Measures
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
Time to achieve <LLOQ undetectable HCV RNA
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
Full Information
NCT ID
NCT01581138
First Posted
April 17, 2012
Last Updated
July 2, 2014
Sponsor
Vertex Pharmaceuticals Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT01581138
Brief Title
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Official Title
A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vertex Pharmaceuticals Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
12 week treatment
Arm Type
Experimental
Arm Title
16 week treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
VX-222
Intervention Description
400 mg tablets twice daily for oral administration
Intervention Type
Drug
Intervention Name(s)
telaprevir
Other Intervention Name(s)
VX-950, INCIVEK, INCIVO, TELAVIC
Intervention Description
1125 mg tablets twice daily for oral administration
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Primary Outcome Measure Information:
Title
The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
Time Frame
12 weeks after the last planned dose of treatment
Secondary Outcome Measure Information:
Title
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
Time Frame
up to 20 weeks
Title
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
Time Frame
24 weeks after the last planned dose of the study drug
Title
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
Time Frame
4 weeks after the last planned dose of the study drug
Title
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
Time Frame
48 weeks either after the last planned dose of study drug or after time of failure
Title
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
Time Frame
up to 16 weeks
Title
Time to achieve <LLOQ undetectable HCV RNA
Time Frame
up to 16 weeks
Title
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
Time Frame
up to 16 weeks
Title
The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
Time Frame
12 weeks after the last planned dose of treatment
Title
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
Time Frame
48 weeks either after the last planned dose of study drug or after time of failure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
Subjects will be treatment naïve
Subjects must have documentation of the presence or absence of cirrhosis
Exclusion Criteria:
History or other clinical evidence of significant or unstable cardiac disease
Evidence of hepatic decompensation
Diagnosed or suspected hepatocellular carcinoma
Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
History of organ transplant, with the exception of corneal transplants and skin grafts
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Vertex Pharmaceuticals Incorporated
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Anaheim
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Englewood
State/Province
Colorado
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Marietta
State/Province
Georgia
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cincinatti
State/Province
Ohio
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Germantown
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
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