An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Copegus (Ribavirin) in Patients With Chronic Hepatitis C, Genotype 2, 3, 1 or 4, Undergoing Opioid Maintenance Therapy (PEGHOPE)
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01416610
First received: August 12, 2011
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This prospective, multi-center, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) in patients with previously untreated chronic hepatitis C, genotype 2, 3, 1 or 4, who are undergoing opioid maintenance therapy. Data will be collected from eligible patients receiving Pegasys and Copegus according to SPC/local guidelines for up to 72 weeks of treatment and 24 weeks of follow-up.
| Condition |
|---|
|
Hepatitis C, Chronic |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Observational, Multicenter Non-interventional Trial Examining Efficacy of Combination Therapy With PEGASYS® Plus COPEGUS® 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Sustained virological response (SVR), defined as percentage of patients with undetectable HCV RNA 24 weeks after completing treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Virological response at end of treatment, defined as percentage of patients with undetectable HCV RNA [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Virological relapse, defined as no SVR in patients with undetectable HCV RNA at end of treatment [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Patient compliance [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
- Quality of life: SF-36 Health Survey/Fatigue Severity Scale/Beck Depression Inventory [ Time Frame: up to 96 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Patients undergoing an opioid maintenance therapy
- Serologic evidence of chronic hepatitis C prior to therapy
- CHC genotype 1, 4, 2 or 3
- Quantifiable serum HCV 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 HIV
- Current diagnosis of a major depression or any psychotic disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416610
Contacts
| Contact: Please reference Study ID Number: ML25159 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Austria | |
| Recruiting | |
| Gratwein, Austria, 8112 | |
| Recruiting | |
| Graz, Austria, 8036 | |
| Recruiting | |
| Innsbruck, Austria, 6020 | |
| Completed | |
| Klagenfurt, Austria, 9020 | |
| Recruiting | |
| Linz, Austria, 4010 | |
| Recruiting | |
| Wien, Austria, 1100 | |
| Recruiting | |
| Wien, Austria, 1030 | |
| Recruiting | |
| Wien, Austria, 1160 | |
| Recruiting | |
| Wien, Austria, 1090 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01416610 History of Changes |
| Other Study ID Numbers: | ML25159 |
| Study First Received: | August 12, 2011 |
| Last Updated: | May 7, 2013 |
| Health Authority: | Austria: Federal Agency for Safety in Health Care (BASG) |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Analgesics, Opioid Peginterferon alfa-2a Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013