Phase 3
Completed N=90
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01054573 ↗
Enrolled (actual)
90
Serious AEs
5.6%
Results posted
Apr 2013
Primary outcomePrimary: The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) — 34.4; 72.7; 81.5; 44.4 Percentage of participants with response
Summary
The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual) |
34.4; 72.7; 81.5; 44.4 | — |
| SECONDARY The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points |
0; 0; 0; 0; 37.5; 77.3 | — |
| SECONDARY Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8 |
28.1; 4.5; 3.7; 11.1 | — |
| SECONDARY Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36 |
31.2; 4.5; 0; 11.1; 9.4; 9.1 | — |
| SECONDARY Percentage of Participants Achieving Rapid Virologic Response (RVR) |
37.5; 77.3; 85.2; 33.3 | — |
| SECONDARY Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR) |
34.4; 72.7; 85.2; 33.3 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
25.0; 9.1; 3.7; 11.1; 15.6; 4.5 | — |
| SECONDARY Percentage of Participants Who Relapsed During Follow-Up |
21.4; 5.3; 4.0; 28.6 | — |
| SECONDARY Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time |
6.63; 6.72; 6.48; 6.76; 1.24; 0.70 | — |
| SECONDARY Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level |
-5.39; -5.83; -5.59; -5.55; -5.51; -5.88 | — |
Eligibility Criteria
Inclusion Criteria
- Patient from the control group of the C216 study who failed therapy for virologic reasons
- Patient must have completed all assessments in the C216 trial
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria
- Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
- Patient has history of decompensated liver disease
- Patient has history of acute or chronic pancreatitis
- Patient has condition that requires use of systemic corticosteroids
- Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
- Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma
Data sourced from ClinicalTrials.gov (NCT01054573). 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.