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Clinical Trials/EUCTR2006-006529-25-PT
EUCTR2006-006529-25-PT
Active, not recruiting
Not Applicable

ong-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

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites2,800 target enrollmentNovember 22, 2010
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment
2800
Status
Active, not recruiting
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 22, 2010
End Date
TBD
Last Updated
10 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Subject must be willing to give written informed consent.
  • •\-Subject must have received at least one dose of any study medication
  • •(peginterferon, ribavirin, boceprevir or narlaprevir) in a previous SPRI Phase
  • •1, 2, or 3 clinical study in which boceprevir or narlaprevir was administered.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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