Phase 3
Completed N=249
3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT01349465 ↗Enrolled (actual)
249
Serious AEs
4.0%
Results posted
Feb 2017
Primary outcomePrimary: Percentage of Participants Maintaining SVR at the Last Available Visit — 100 Percentage of participants
◆ Published Evidence
Emerging
6citations · ~1 / year
A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection.
Summary
The purpose of this study is to investigate durability of SVR in chronic HCV patients who achieved SVR in the previous study with TMC435-containing regimen and time for resistance associated mutations to return to baseline in chronic HCV patients who did not achieve SVR in the previous study with TMC435-containing regimen.
Linked Publications
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A 3-year follow-up study after treatment with simeprevir in combination with pegylated interferon-α and ribavirin for chronic hepatitis C virus infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Maintaining SVR at the Last Available Visit |
100 | — |
| PRIMARY Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study |
0.0; 0.0; 86.0; 7.0 | — |
| PRIMARY Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study |
0.0; 0.0; 88.9; 0.0 | — |
| PRIMARY Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study |
0.0; 0.0; 85.3; 8.8 | — |
| SECONDARY Percentage of Participants With Late Viral Relapse |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability |
4; 1; 10; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have previously participated in a Phase IIb or Phase III study
- Must have received at least one dose of TMC435 in that study
- Has completed the last post-therapy follow-up visit of the previous (LPVPS) study
Exclusion Criteria
- Must be currently enrolled or plan to enroll in another study with an investigational drug or invasive investigational medical device
- Have received antiviral or immunomodulating treatment, including therapeutic vaccines, for hepatitis C virus (HCV) between LPVPS and the screening visit of present study
Data sourced from ClinicalTrials.gov (NCT01349465) and the linked publication. 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.