A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT00535847
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Telaprevir Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Pegylated interferon alfa 2a Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Ribavirin Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Pegylated interferon alfa 2a Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. Other Pegylated interferon alfa 2a Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week Telaprevir Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week Ribavirin Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Other Telaprevir Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group. Other Ribavirin Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.
- Primary Outcome Measures
Name Time Method Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment 24 weeks after the completion of treatment (up to Week 72) The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) Baseline through Week 48 AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
- Secondary Outcome Measures
Name Time Method Percentage of Prior Relapsers With Undetectable HCV RNA 24 weeks after the completion of treatment (up to Week 72) Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment 48 weeks after completion of treatment (up to Week 96) The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Percentage of Subjects With End of Treatment Response End of treatment (up to Week 48) Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response Baseline up to Week 72 Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than \[\<\] 1-log10 decrease in HCV RNA at Week 4 or \<2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than \[\>\] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Trial Locations
- Locations (41)
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
South Denver Gastroenterology
🇺🇸Englewood, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Digestive and Liver Disease Clinic
🇺🇸Baton Rouge, Louisiana, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Virology Treatment Center, Maine Medical Center
🇺🇸Portland, Maine, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
St Louis University
🇺🇸St Louis, Missouri, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Columbia Gastroenterology Associates, PA
🇺🇸Columbia, South Carolina, United States
Liver Institute at Methodist Dallas
🇺🇸Dallas, Texas, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
University of Virginia Health Systems
🇺🇸Charlottesville, Virginia, United States
McGuire DVAMC
🇺🇸Richmond, Virginia, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
University of Calgary Medical Clinic
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of British Columbia Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hospital Henri Mondor
🇫🇷Creteil, France
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
University of Cologne
🇩🇪Cologne, Germany
Uniklinik Duesseldorf
🇩🇪Dusseldorf, Germany
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Erasmus MC Medical Center
🇳🇱Rotterdam, Netherlands
Fundacion de Investigation de Diego
🇵🇷Santurce, Puerto Rico
Kaiser Permanente Internal Medicine
🇺🇸San Diego, California, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
University of Miami Center for Liver Diseases
🇺🇸Miami, Florida, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States