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

NCT ID: NCT01416610

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-10-31

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 hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible participants receiving Pegasys and Copegus treatment as prescribed by treating physician and treatment-free follow-up period of 24 weeks.

Conditions

Hepatitis C, Chronic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Participants

Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin

Gratwein, , Austria

Lkh-Univ. Klinikum Graz

Graz, , Austria

Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin

Innsbruck, , Austria

Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung

Klagenfurt, , Austria

A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.

Linz, , Austria

Gesundheitszentrum Wien Mitte

Vienna, , Austria

Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.

Vienna, , Austria

Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie

Vienna, , Austria

Kaiser Franz Josef Spital; Iv. Medizinische Abt.

Vienna, , Austria

Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung

Vienna, , Austria

Countries

Austria

References

Gschwantler M, Laferl H, Vogel W, Korak W, Moser S, Hofer H, Bauer B, Schleicher M, Bognar B, Bischof M, Stauber R, Maieron A, Ferenci P; Austrian Hepatitis Study Group. Efficacy of peginterferon plus ribavirin in patients receiving opioid substitution therapy : Final results of the Austrian PegHope study. Wien Klin Wochenschr. 2018 Jan;130(1-2):54-61. doi: 10.1007/s00508-017-1263-2. Epub 2017 Sep 12.

Reference Type: DERIVED

PMID: 28900714 (View on PubMed)

Other Identifiers

ML25159

Identifier Type: -

Identifier Source: org_study_id