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Clinical Trials/EUCTR2011-006132-24-GB
EUCTR2011-006132-24-GB
Active, not recruiting
Phase 1

A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C patients

ovartis Pharma Services AG0 sites105 target enrollmentMay 10, 2012
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ConditionsChronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.
Sponsor
ovartis Pharma Services AG
Enrollment
105
Status
Active, not recruiting
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 10, 2012
End Date
January 23, 2014
Last Updated
5 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\-Written informed consent must be obtained before any assessment is performed
  • •\-Males or females aged 18 or greater
  • •\-Have previously completed a Novartis\-sponsored hepatitis C study and received alisporivir or a direct antiviral agent
  • •\-Have not acheived SVR24
  • •\-Are able to comply with visit schedule
  • •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 650
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •\-Use of any investigational drugs within 5 half\-lives of enrollment, or within 30 days of that medication, whichever is longer
  • •\-Previous use of any course of hepatitis C therapy since the end of the Novartis\-sponsored hepatitis C study

Outcomes

Primary Outcomes

Not specified

Similar Trials

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A 3-year follow-up study in chronic hepatitis C patients who failed to achieve sustained virologic response during Novartis-sponsored alisporivir studiesChronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.MedDRA version: 14.1Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
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