Status:
TERMINATED
Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepacivirus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 follo...
Detailed Description
In Part 1, participants who previously participated in one of nine boceprevir studies (P03523 \[NCT00423670\], P03659 \[NCT00160251\], P04487 \[No NCT\], P05101 \[NCT00708500\], P05216 \[NCT00705432\]...
Eligibility Criteria
Inclusion
- Participant must be willing to give written informed consent and be able to adhere to the visit schedule.
- Participant must have received at least one dose of boceprevir or narlaprevir in a previous Phase 1, 2, or 3 clinical study.
Exclusion
- 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 participant previously participated.
- Any condition which in the opinion of the Investigator would make the participant unsuitable for enrollment.
Key Trial Info
Start Date :
February 20 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2014
Estimated Enrollment :
1954 Patients enrolled
Trial Details
Trial ID
NCT00689390
Start Date
February 20 2007
End Date
October 13 2014
Last Update
September 11 2018
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