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Three-year Follow-up of Subjects After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063AM1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00689390
First received: May 27, 2008
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  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:

Drug Information available for: Boceprevir
U.S. FDA Resources

Further study details as provided by Merck:

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 ]

Estimated Enrollment: 2800
Study Start Date: February 2007
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00689390     History of Changes
Other Study ID Numbers: P05063, 2006-006529-25
Study First Received: May 27, 2008
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013