Status:
COMPLETED
An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Participants With Chronic Hepatitis C (CHC), Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in participants with previously untreated chronic ...
Eligibility Criteria
Inclusion
- Adult participants, \>/= 18 years of age
- Participants undergoing an opioid maintenance therapy
- Serologic evidence of CHC prior to therapy
- CHC genotype 2, 3, 1 or 4
- Quantifiable serum hepatitis C (HCV) ribonucleic acid (RNA)
- All fertile males and females receiving ribavirin must use two forms of effective contraception during treatment with study drugs and for 7 months after completion of treatment
Exclusion
- Harmful use of psychoactive substances (including excessive alcohol consumption) that precludes successful participation in the study at the discretion of the investigator
- Pegylated interferon, standard interferon or ribavirin therapy at any time prior to initiation of the study
- Co-infection with hepatitis A, hepatitis B or Human Immunodeficiency Virus (HIV)
- Current diagnosis of a major depression or any psychotic disorder
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01416610
Start Date
April 1 2010
End Date
October 1 2014
Last Update
April 10 2017
Active Locations (10)
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1
Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
Gratwein, Austria, 8112
2
Lkh-Univ. Klinikum Graz
Graz, Austria, 8036
3
Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
Innsbruck, Austria, 6020
4
Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
Klagenfurt, Austria, 9020