A Study of Combination Treatment With PEGASYS (Peginterferon Alfa-2a (40KD) Plus 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:
NCT00800748
First received: December 1, 2008
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
This 3 arm study will assess the safety and efficacy of combination treatment with PEGASYS + Copegus in patients with chronic hepatitis C. Three groups of patients will be studied; 1) those with elevated ALT level, 2) those with normal ALT level, and 3) those with HIV co-infection. Patients with genotype 1, 4, 5 or 6 will receive PEGASYS 180 micrograms sc once weekly + Copegus 1000-1200mg po daily (dependent on body weight) for 48 weeks, those with genotype 2 or 3 will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 24 weeks, and all patients with HIV co-infection will receive PEGASYS 180 micrograms sc once weekly + Copegus 800mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [Pegasys] Drug: ribavirin [Copegus] |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open Label Study Assessing the Safety and Effect on Viral Response of Combination Therapy With PEGASYS + COPEGUS in Selected Groups of Patients With Chronic Viral Hepatitis C |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Occurrence rate and intensity of adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Sustained viral response [ Time Frame: End of treatment (weeks 24 or 48) ] [ Designated as safety issue: No ]
- Viral response rate [ Time Frame: At week 12, and at end of treatment (weeks 24 or 48) ] [ Designated as safety issue: No ]
| Enrollment: | 373 |
| Study Start Date: | January 2006 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
|
| Experimental: 2 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks (genotype 1, 4, 5, 6), or 24 weeks (genotype 2, 3)
Drug: ribavirin [Copegus]
1000-1200mg po daily for 48 weeks (genotype 1, 4, 5, 6) or 800mg po daily for 24 weeks (genotype 2,3)
|
| Experimental: 3 |
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Drug: ribavirin [Copegus]
800mg 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;
- chronic hepatitis C, with detectable serum HCV RNA;
- scheduled for treatment with PEGASYS;
- compensated liver disease.
Exclusion Criteria:
- chronic liver disease other than chronic hepatitis C;
- active HAV or HBV infection;
- therapy with any systemic antiviral, antineoplastic or immunomodulatory treatment <= 6 months prior to first dose of study drug.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00800748
Locations
| Czech Republic | |
| Beroun, Czech Republic | |
| Brno, Czech Republic, 62500 | |
| Ceska Lipa, Czech Republic | |
| Ceské Budejovice, Czech Republic, 370 87 | |
| Chomutov, Czech Republic | |
| Decin, Czech Republic, 0 | |
| Havirov, Czech Republic | |
| Havlickuv Brod, Czech Republic | |
| Hradec Kralove, Czech Republic, 500 12 | |
| Hradec Kralove, Czech Republic | |
| Jablonec/nisou, Czech Republic, 466 60 | |
| Jihlava, Czech Republic | |
| Karlovy Vary, Czech Republic | |
| Kolin, Czech Republic | |
| Liberec, Czech Republic | |
| Melnik, Czech Republic | |
| Most, Czech Republic | |
| Olomouc, Czech Republic | |
| Opava, Czech Republic | |
| Ostrava, Czech Republic, 708 52 | |
| Pardubice, Czech Republic | |
| Praha, Czech Republic, 00000 | |
| Praha, Czech Republic, 180 01 | |
| Praha, Czech Republic | |
| Praha, Czech Republic, 140 00 | |
| Praha 2, Czech Republic, 128 08 | |
| Prostejov, Czech Republic | |
| Usti Nad Labem, Czech Republic | |
| Slovakia | |
| Banska Bystrica, Slovakia, 975 17 | |
| Bratislava, Slovakia, 851 07 | |
| Bratislava, Slovakia, 833 05 | |
| Kosice, Slovakia, 04001 | |
| Kosice, Slovakia, 040 01 | |
| Martin, Slovakia, 036 59 | |
| Trencin, Slovakia, 911 07 | |
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: | NCT00800748 History of Changes |
| Other Study ID Numbers: | ML19387 |
| Study First Received: | December 1, 2008 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Czech Republic: State Institute for Drug Control |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Hepatitis, Chronic 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