Phase 2
Completed N=117
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
Source: ClinicalTrials.gov NCT00535847 ↗Enrolled (actual)
117
Serious AEs
9.4%
Results posted
Jul 2011
Primary outcomePrimary: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment — 60.5; 52.9; 100.0 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment |
60.5; 52.9; 100.0 | — |
| PRIMARY Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
77; 31; 2; 7; 3; 1 | — |
| SECONDARY Percentage of Prior Relapsers With Undetectable HCV RNA |
96.0; 100.0; 100.0 | — |
| SECONDARY Percentage of Subjects With End of Treatment Response |
72.8; 64.7; 100.0 | — |
| SECONDARY Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment |
83.1; 70.0 | — |
| SECONDARY Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response |
12; 5; 7; 27; 15; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Data sourced from ClinicalTrials.gov (NCT00535847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.