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A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma HCV RNA Levels Did Not Respond to Therapy

This study has been completed.
Sponsor:
Collaborator:
Tibotec, Inc
Information provided by:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00535847
First received: September 25, 2007
Last updated: June 22, 2011
Last verified: June 2011
History of Changes

September 25, 2007
June 22, 2011
October 2007
February 2010   (final data collection date for primary outcome measure)
  • Proportion of Subjects With Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
    Proportion of Subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment)
  • Adverse Events and Clinical Laboratory Assessments [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • 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
  • Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
    Proportion of subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment) in prior relapsers
  • Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
    Proportion of Subjects with End of Treatment Response (undetectable HCV RNA at end of treatment), overall
  • Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 48 weeks after completion of treatment ] [ Designated as safety issue: No ]
    Proportion of Subjects with SVR48 among Subjects Completing Assigned Treatment, Overall
  • Cross Tabulation of eRVR and SVR Responses in Study 107 With Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: throughout study ] [ Designated as safety issue: No ]
    Number of subjects who achieved eRVR and/or SVR24
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 HCV 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, VX05-950-104, and VX05-950-104EU who stopped treatment due to inadequate response to treatment. Safety, tolerability, and HCV RNA levels will be collected.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
  • Drug: telaprevir
    tablet
    Other Name: VX-950
  • Drug: ribavirin
    tablet
  • Drug: Peg-interferon Alfa-2a
    Solution for Injection
  • Experimental: T12/PR24
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Drug: Peg-interferon Alfa-2a
  • Experimental: T12/PR48
    Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 36 weeks
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Drug: Peg-interferon Alfa-2a
  • Experimental: Other
    Subjects in this arm were receiving Telaprevir + Peg-IFN + RBV for 12 weeks. Subjects with a partial response, viral breakthrough, or relapse in the parent study, and who discontinued treatment before Week 12, were included in the "Other" treatment group.
    Interventions:
    • Drug: telaprevir
    • Drug: ribavirin
    • Drug: Peg-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
Not Provided
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in the control arm of Study VX06-950-106, VX05-950-104 or VX05-950-104EU
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
Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Tibotec, Inc
Study Director: Nathalie Adda, MD Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2011

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