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Clinical Trials/EUCTR2006-006529-25-DE
EUCTR2006-006529-25-DE
Active, not recruiting
Phase 1

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

Schering-Plough Research Institute0 sites1,954 target enrollmentFebruary 1, 2007
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Conditionsong-term Follow-up of prior study participantsMedDRA version: 14.0Level: PTClassification code 10019641Term: Hepatic cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
ong-term Follow-up of prior study participants
Sponsor
Schering-Plough Research Institute
Enrollment
1954
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 1, 2007
End Date
October 13, 2014
Last Updated
6 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

Similar Trials

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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
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EUCTR2006-006529-25-FRSchering-Plough Research Institute1,954