A Study of Combination Treatment With Pegasys (Peginterferon Alfa) and Copegus (Ribavirin)in Patients With Chronic Hepatitis C
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00940420
First received: July 6, 2009
Last updated: January 17, 2012
Last verified: January 2012
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Purpose
This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [Pegasys] Drug: Copegus (ribavirin) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Tolerability of Ribavirin (Ro 20-9963) in Combination With Peginterferon Alfa in Patients With Chronic Hepatitis C |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- safety and tolerability with regard to clinical AEs and laboratory parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 weeks follow-up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- safety with regard to hematological parameters [ Time Frame: assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up ] [ Designated as safety issue: No ]
| Enrollment: | 2613 |
| Study Start Date: | October 2002 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 24 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 24 weeks
|
| Experimental: B |
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc once weekly for 48 weeks
Drug: Copegus (ribavirin)
800 - 1200 mg po daily for 48 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients >/= 18 years of age
- serologic evidence of chronic hepatitis C infection
- compensated liver disease
- negative pregnancy test and in both males and females use of 2 forms of contraception during study and 6 months after treatment
Exclusion Criteria:
- history or other evidence of a medical condition associated with chronic liver disease other than HCV
- hepatitis A, hepatitis B or HIV infection
- hepatocellular carcinoma
- severe concomitant disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940420
Locations
| Israel | |
| Afula, Israel, 18101 | |
| Ashkelon, Israel, 78278 | |
| Bat Yam, Israel | |
| Beer Sheva, Israel, 84105 | |
| Hadera, Israel, 38100 | |
| Haifa, Israel, 33394 | |
| Haifa, Israel, 31096 | |
| Haifa, Israel, 34362 | |
| Holon, Israel, 58100 | |
| Jerusalem, Israel, 91120 | |
| Kfar Saba, Israel, 44281 | |
| Nahariya, Israel, 22100 | |
| Nazareth, Israel | |
| Petach Tikva, Israel | |
| Petach Tikva, Israel, 49100 | |
| Ramat Gan, Israel, 52621 | |
| Rehovot, Israel, 76100 | |
| Safed, Israel, 13110 | |
| Tel Aviv, Israel, 64239 | |
| Zerifin, Israel, 70300 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Disclosures Group, Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT00940420 History of Changes |
| Other Study ID Numbers: | ML16837 |
| Study First Received: | July 6, 2009 |
| Last Updated: | January 17, 2012 |
| Health Authority: | Israel: Israeli Ministry of Health |
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 Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013