Three-year Follow-up of Subjects After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063AM1)
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | February 2007 |
| End Date: | January 2016 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir Was Administered for the Treatment of Chronic Hepatitis C
Study P05063 is a 3-year follow-up study in subjects previously treated with boceprevir or
narlaprevir in a Phase 1, 2, or 3 clinical study. Subjects will be followed for up to 3.5
years after the end of their participation in the treatment protocol to document maintenance
of the antiviral response (for sustained responders) and to characterize the long-term
safety after use of this novel therapeutic regimen.
Inclusion Criteria:
- Subject must be willing to give written informed consent and be able to adhere to the
visit schedule.
- Subject must have received at least one dose of boceprevir or narlaprevir in a
previousPhase 1, 2, or 3 clinical study.
Exclusion Criteria:
- Concurrent participation in any other clinical study for the treatment of chronic
hepatitis C.
- Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after
completion of, or discontinuation from, the SPRI Phase 1, 2, or 3 clinical study in
which the subject previously participated.
- Any condition which in the opinion of the Investigator would make the subject
unsuitable for enrollment.
We found this trial at
34
sites
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