A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
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:
NCT01429792
First received: September 5, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 & 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 & 3) or 48 weeks (genotype 1 & 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
| 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: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin) |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Rate of genotype 1 patients with partial early viral response (pEVR, a 2-log decrement but with detectable HCV RNA at Week 12 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 1 patients with complete early viral response (cEVR, undetectable HCV RNA at Week 12 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 1 patients with pEVR at Week 12 and undetectable HCV RNA at Week 24 [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 2 & 3 patients not achieving rapid viral response (RVR, defined as undetectable HCV RNA at Week 4 of standard treatment) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 2 & 3 patients achieving virological response at Week 24 (EOT - end of treatment, defined as undetectable HVC RNA) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Rate of genotype 4 patients with partial EVR [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 4 patients with complete EVR [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Rate of genotype 4 patients with pEVR at Week 12 and undetectable HCV RNA at Week 24 [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: peginterferon alfa-2a [Pegasys]
standard treatment, subcutaneously weekly
Drug: ribavirin [Copegus]
standard treatment, orally daily
|
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, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
Exclusion Criteria:
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment </= 6 months prior to study day
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429792
Contacts
| Contact: Please reference Study ID Number: ML21779 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Israel | |
| Completed | |
| Afula, Israel, 18101 | |
| Completed | |
| Ashdod, Israel, 77444 | |
| Active, not recruiting | |
| Ashkelon, Israel, 78278 | |
| Completed | |
| Bat Yam, Israel | |
| Active, not recruiting | |
| Beer Sheva, Israel, 84105 | |
| Completed | |
| Beer Sheva, Israel, 8410101 | |
| Completed | |
| Haifa, Israel, 33394 | |
| Completed | |
| Haifa, Israel, 34362 | |
| Active, not recruiting | |
| Haifa, Israel, 31096 | |
| Active, not recruiting | |
| Holon, Israel, 58100 | |
| Terminated | |
| Jerusalem, Israel, 91120 | |
| Completed | |
| Jerusalem, Israel, 95146 | |
| Active, not recruiting | |
| Kfar Saba, Israel, 44281 | |
| Active, not recruiting | |
| Nahariya, Israel, 22100 | |
| Active, not recruiting | |
| Nazareth, Israel | |
| Active, not recruiting | |
| Petach Tikva, Israel | |
| Active, not recruiting | |
| Petach Tikva, Israel, 49100 | |
| Completed | |
| Ramat Gan, Israel, 52621 | |
| Active, not recruiting | |
| Rehovot, Israel, 76100 | |
| Active, not recruiting | |
| Rishon Lezion, Israel, 75299 | |
| Active, not recruiting | |
| Safed, Israel, 13110 | |
| Recruiting | |
| Tel Aviv, Israel, 64353 | |
| Terminated | |
| Tel Aviv, Israel, 67891 | |
| Completed | |
| Tel Aviv, Israel, 64239 | |
| Active, not recruiting | |
| Tiberias, Israel | |
| Active, not recruiting | |
| Zerifin, Israel, 70300 | |
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: | NCT01429792 History of Changes |
| Other Study ID Numbers: | ML21779 |
| Study First Received: | September 5, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | Israel: 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 19, 2013