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
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01416610
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With Sustained Virological Response 24 Weeks After Completing Treatment (SVR24) 24 weeks after completing treatment, within 3 years, 6 months SVR24 is defined as percentage of participants with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing treatment, using a last observation carried forward (LOCF) approach. Percentage is based on the number of non-missing observations (total).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With SVR 12 12 weeks after completing treatment, within 3 years, 6 months SVR 12 is defined as percentage of participants with undetectable HCV RNA 12 weeks after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Percentage of Participants With Virological Relapse by end of follow-up, within 3 years, 6 months Virological relapse is defined as no SVR24 in a participant with undetectable HCV RNA at end of treatment who has at least one post-treatment polymerase chain reaction (PCR) result available, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Percentage of Participants With End of Treatment Response at end of treatment, within 3 years, 6 months A participant was considered to have end of treatment response if there was undetectable HCV RNA after completing treatment, using a LOCF approach. Percentage is based on the number of non-missing observations (total).
Beck Depression Inventory (BDI) Score by Visit at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months The BDI questionnaire items were scored by generating the sum of the responses to all answered items. Each result was categorized into one of four categories: 0-13= no depression or clinically not significant or in remission; 14-19= mild depression; 20-28= moderate depression; or 29-63= severe depression. Mean scores are presented by visit.
Short Form Health Survey (SF-36) Scores by Visit at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months The SF-36 questionnaire items were scored and transformed according to the SF-36 Health Survey Manual \& Interpretation Guide. Summary scores for SF-36 dimensions of physical functioning, role functioning, bodily pain, general health, vitality, social functioning, and mental health were scored on a scale of 0 (worst) to 100 (best), and health transition was scored on a scale of 0 (worst) to 5 (best). Summary SF-36 scores are reported by category and by visit.
Fatigue Severity Scale (FSS) Score by Visit at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months The Fatigue Severity Scale (FSS) consists of 9 questions, each answered within a range of 1-7, where lower scores indicate less fatigue in everyday life. The FSS score is the mean of the 9 numbers. Mean scores are presented by visit.
Beschwerdeliste (BL) Score by Visit at baseline, week 12, end of treatment and end of follow-up within 3 years, 6 months The BL questionnaire items were scored by calculating the average response to all answered items. Items can be graded 1="stark" (affliction is strong) to 4="gar nicht" (not present). The higher the BL score, the less afflictions were present for a participant. Mean scores are presented by visit.
Trial Locations
- Locations (10)
Lkh-Univ. Klinikum Graz
🇦🇹Graz, Austria
Lkh Hoergas-Enzenbach; Abt. Für Innere Medizin
🇦🇹Gratwein, Austria
Lkh innsbruck - univ. Klinikum innsbruck - Tiroler landeskrankenanstalten ges.m.b.h.; Innere Medizin
🇦🇹Innsbruck, Austria
Kaiser Franz Josef Spital; Iv. Medizinische Abt.
🇦🇹Wien, Austria
Klinikum Klagenfurt am Wörthersee; 2. Medizinische Abteilung
🇦🇹Klagenfurt, Austria
A.Ö. Krankenhaus Der Elisabethinen Linz; Iv. Med. Abtl.
🇦🇹Linz, Austria
Krankenanstalt Rudolfstiftung; Iv. Med. Abtl.
🇦🇹Wien, Austria
Wilhelminenspital; 6. Medizinische Abteilung Wilhelminenspital; 6. Medizinische Abteilung
🇦🇹Wien, Austria
Gesundheitszentrum Wien Mitte
🇦🇹Wien, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin III - Gastroenterologie & Hepatologie
🇦🇹Wien, Austria