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

This study has been completed.
Sponsor:
Collaborator:
Tibotec, Inc
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00535847
First received: September 25, 2007
Last updated: July 9, 2014
Last verified: July 2014

September 25, 2007
July 9, 2014
October 2007
February 2010   (final data collection date for primary outcome measure)
  • Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment [ Time Frame: 24 weeks after the completion of treatment (up to Week 72) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline through Week 48 ] [ Designated as safety issue: Yes ]
    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.
  • Plasma HCV RNA levels measured using the COBAS TaqMan HCV test [ Time Frame: 2009 ]
  • Clinical chemistry and hematology assessments, vital signs, physical examinations, and adverse events [ Time Frame: 2009 ]
Complete list of historical versions of study NCT00535847 on ClinicalTrials.gov Archive Site
  • Percentage of Prior Relapsers With Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment (up to Week 72) ] [ Designated as safety issue: No ]
    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 End of Treatment Response [ Time Frame: End of treatment (up to Week 48) ] [ Designated as safety issue: No ]
    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).
  • Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment [ Time Frame: 48 weeks after completion of treatment (up to Week 96) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to Week 72 ] [ Designated as safety issue: No ]
    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.
HCV RNA sequencing [ Time Frame: 2009 ]
Not Provided
Not Provided
 
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
A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: Telaprevir
    Tablet
    Other Name: VX-950
  • Drug: Ribavirin
    Tablet
  • Drug: Pegylated interferon alfa 2a
    Solution for Injection
  • Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
    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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Pegylated interferon alfa 2a
  • Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
    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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Pegylated interferon alfa 2a
  • Experimental: Other
    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.
    Interventions:
    • Drug: Telaprevir
    • Drug: Ribavirin
    • Drug: Pegylated interferon alfa 2a
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   France,   Germany,   Netherlands,   Puerto Rico,   United Kingdom
 
NCT00535847
VX06-950-107
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec, Inc
Study Director: Nathalie Adda, MD Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP