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Clinical Trials/EUCTR2011-000945-19-HU
EUCTR2011-000945-19-HU
Active, not recruiting
Not Applicable

A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead Sponsored Trials in Subjects with Chronic Hepatitis C Infection

Gilead Sciences Inc.0 sites740 target enrollmentOctober 20, 2011
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ConditionsGenotype 1 Hepatitis C Virus InfectionMedDRA version: 14.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsCopegusPegasys

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Genotype 1 Hepatitis C Virus Infection
Sponsor
Gilead Sciences Inc.
Enrollment
740
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2011
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Willing and able to provide written informed consent;
  • •2\. Have previously participated in a Gilead\-sponsored hepatitis C study and received at least one Gilead OAV;
  • •3\. Have achieved SVR in a Gilead\-sponsored study, as defined in the original treatment protocol;
  • •4\. Be willing and able to comply with the visit schedule and protocol\-mandated procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 666
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 74

Exclusion Criteria

  • •1\. Subject plans to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow\-up Registry.
  • •2\. History of clinically\-significant illness or any other major medical disorder that may interfere with subject follow\-up, assessments or compliance with the protocol.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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A long-term study to follow patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.MedDRA version: 18.0Level: SOCClassification code 10021881Term: Infections and infestationsSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]Genotype 1 Hepatitis C Virus InfectionMedDRA version: 18.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
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