Clinical trial NCT01416610: 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
Official title: A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD) Plus COPEGUS® (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing an Opioid Maintenance-Therapy With Special Focus on Patient Compliance and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with chronic hepatitis C (CHC), Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy

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.


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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24)
timeFrame: 24 weeks after completing treatment, within 3 years, 6 months
Secondary outcomes:
measure: Percentage of Participants With SVR 12
timeFrame: 12 weeks after completing treatment, within 3 years, 6 months
measure: Percentage of Participants With End of Treatment Response
timeFrame: at end of treatment, within 3 years, 6 months
measure: Percentage of Participants With Virological Relapse
timeFrame: by end of follow-up, within 3 years, 6 months
measure: Short Form Health Survey (SF-36) Scores by Visit
timeFrame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
measure: Fatigue Severity Scale (FSS) Score by Visit
timeFrame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
measure: Beschwerdeliste (BL) Score by Visit
timeFrame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
measure: Beck Depression Inventory (BDI) Score by Visit
timeFrame: at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months
Other outcomes:
Locations:
city: Gratwein
country: Austria
facility: Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz
city: Innsbruck
country: Austria
facility: Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
city: Linz
country: Austria
facility: A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
city: Wien
country: Austria
facility: Gesundheitszentrum Wien Mitte
city: Wien
country: Austria
facility: Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
city: Wien
country: Austria
facility: Kaiser Franz Josef Spital; Iv. Medizinische Abt.
city: Wien
country: Austria
facility: Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.