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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00689390
First received: May 27, 2008
Last updated: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic
Hepacivirus
Drug: Boceprevir (SCH 503034)
Drug: Narlaprevir (SCH 900518)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Durability of virologic response in subjects with chronic hepatitis C who were sustained responders 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 study. [ Time Frame: Three-year follow-up study with 8 scheduled study visits at Baseline and Months 3, 6, 12, 18, 24, 30 and 36 ] [ Designated as safety issue: No ]
  • Long-term safety in subjects treated with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 study. [ Time Frame: 3 year follow-up study with 8 scheduled study visits at Baseline and Months 3, 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]
  • Hepatitis C virus (HCV) sequence variants in subjects treated with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 study. [ Time Frame: Three-year follow-up study with 8 scheduled study visits at Baseline and Months 3, 6, 12, 18, 24, 30, and 36 ] [ Designated as safety issue: No ]

Enrollment: 1954
Study Start Date: February 2007
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment with boceprevir or narlaprevir in a previous study
Study P05063 is a three-year follow-up of subjects previously treated with boceprevir or narlaprevir. No treatment was administered in Study P05063
Drug: Boceprevir (SCH 503034)
Study P05063 is a long-term follow-up of previous treatment with boceprevir or narlaprevir.
Drug: Narlaprevir (SCH 900518)
Study P05063 is a long-term follow-up of previous treatment with boceprevir or narlaprevir.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00689390     History of Changes
Other Study ID Numbers: P05063, 2006-006529-25
Study First Received: May 27, 2008
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 30, 2014