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Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)

Hepatitis C, Chronic Clinical Trial

Official title:
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

Clinical Trial Summary

Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants 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 therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.

Clinical Trial Description

In Part 1, participants who previously participated in one of nine boceprevir studies (P03523 [NCT00423670], P03659 [NCT00160251], P04487 [No NCT], P05101 [NCT00708500], P05216 [NCT00705432], P05411 [NCT00959699], P05514 [NCT00910624], P05685 [NCT00845065], and P06086 [NCT01023035]) were followed for response. In Part 2, participants who previously participated in one narlaprevir study (P05104 [NCT00797745]) were followed for response. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00689390
Study type Interventional
Source Merck Sharp & Dohme Corp.
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date February 20, 2007
Completion date October 13, 2014
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