A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
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:
NCT01033448
First received: December 15, 2009
Last updated: May 23, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C, Chronic |
Drug: peginterferon alfa-2a [Pegasys] Drug: COPEGUS |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Efficacy: end of treatment response rate (virological), sustained viral response [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety and Tolerability: AEs, laboratory parameters [ Time Frame: AEs: throughout study; laboratory assessments: weeks 8, 16, 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single arm |
Drug: peginterferon alfa-2a [Pegasys]
PEGASYS 180 micrograms sc once weekly for 24 weeks
Drug: COPEGUS
COPEGUS 800 mg or 1000-1200 mg po for 24 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, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
Exclusion Criteria:
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033448
Contacts
| Contact: Reference Study ID Number: ML21778 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | global.rochegenentechtrials@roche.com |
Locations
| Israel | |
| Completed | |
| Afula, Israel, 18101 | |
| Recruiting | |
| Ashdod, Israel, 77444 | |
| Not yet recruiting | |
| Ashkelon, Israel, 78278 | |
| Active, not recruiting | |
| Bat Yam, Israel | |
| Recruiting | |
| Beer Sheva, Israel, 84105 | |
| Active, not recruiting | |
| Haifa, Israel, 33394 | |
| Active, not recruiting | |
| Haifa, Israel, 34362 | |
| Recruiting | |
| Haifa, Israel, 31096 | |
| Completed | |
| Holon, Israel, 58100 | |
| Recruiting | |
| Jerusalem, Israel, 95146 | |
| Completed | |
| Jerusalem, Israel, 91120 | |
| Completed | |
| Kfar Saba, Israel, 44281 | |
| Recruiting | |
| Nahariya, Israel, 22100 | |
| Completed | |
| Nazareth, Israel | |
| Recruiting | |
| Petach Tikva, Israel, 49100 | |
| Not yet recruiting | |
| Petach Tikva, Israel | |
| Not yet recruiting | |
| Ramat Gan, Israel, 52621 | |
| Recruiting | |
| Rehovot, Israel, 76100 | |
| Completed | |
| Rishon Lezion, Israel, 75299 | |
| Recruiting | |
| Safed, Israel, 13110 | |
| Not yet recruiting | |
| Tel Aviv, Israel, 64239 | |
| Active, not recruiting | |
| Tel Aviv, Israel, 64353 | |
| Terminated | |
| Tel Aviv, Israel, 67891 | |
| Terminated | |
| Tiberias, Israel | |
| 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: | NCT01033448 History of Changes |
| Other Study ID Numbers: | ML21778 |
| Study First Received: | December 15, 2009 |
| Last Updated: | May 23, 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 23, 2013