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| Sponsor: | National Taiwan University Hospital |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT00154869 |
Purpose
The investigators' pilot study indicates that hepatitis C virus (HCV)- and hepatitis B virus (HBV)-coinfected patients with predominantly active hepatitis C and those with predominantly active hepatitis B may need different anti-viral regimens. Since in the majority of these coinfected patients the hepatitis activity is more likely due to HCV than to HBV, the optimal therapeutic regimen for HCV- and HBV-coinfected patients with predominantly active hepatitis C will first be investigated. The combination therapy using pegylated interferons (IFNs) such as PEG-IFN alfa-2a has been shown to have a superior efficacy than that using conventional IFN in the treatment of monoinfected chronic hepatitis C. This new combination therapy might also further enhance the treatment efficacy in HCV- and HBV- coinfected patients. The investigators therefore propose to initiate a trial comparing the efficacy of pegylated IFN plus ribavirin (RBV) in dual chronic hepatitis B and C versus that in chronic hepatitis C only, for both HCV genotype 1 and 2/3 patients. The efficacy using a 24-week combination therapy in the sustained clearance of serum HCV RNA is equivalent to that using a 48-week combination therapy in patients with HCV genotype non-1 [Hadziyannis et al, EASL 2002]. A 48-week course of pegylated IFN and RBV combination therapy, in contrast, has been shown to yield a better efficacy in the sustained clearance of serum HCV RNA in patients with HCV genotype 1 than a 24-week combination therapy in western countries [Hadziyannis et al, EASL 2002; Poynard et al, 1998]. The primary objective of the current proposal is to investigate and compare the efficacy of combination therapy using pegylated IFN plus RBV on the clearance of serum HCV RNA in both dually infected patients with a dominant HCV infection and HCV monoinfected patients. Therefore, in this proposal, the treatment duration will be 24 weeks for HCV genotype 2/3 in patients with dual chronic hepatitis C and B and in patients with monoinfected HCV, and will be 48 weeks for HCV genotype 1 in patients with dual chronic hepatitis C and B and in patients with monoinfected HCV.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B, Chronic Hepatitis C, Chronic |
Drug: Peginterferon Alfa-2a plus Ribavirin |
Phase III |
| 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, Comparative, Multi-Center Study, to Evaluate the Efficacy and Safety of Peginterferon Alfa-2a Plus Ribavirin in the Treatment of Patients With Chronic Hepatitis C/Hepatitis B Co-Infection and Chronic Hepatitis C |
| Estimated Enrollment: | 320 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | August 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must:
Exclusion Criteria:
Contacts and Locations| Contact: Pei-Jer Chen, M.D.; Ph.D. | 886-2-23123456 ext 7072 | peijer@ha.mc.ntu.edu.tw |
| Taiwan | |
| Department of Internal Medicine | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Pei-Jer Chen, M.D.; Ph.D. 886-2-23123456 ext 7072 peijer@ha.mc.ntu.edu.tw | |
| Principal Investigator: Pei-Jer Chen, M.D.; Ph.D. | |
| Principal Investigator: | Pei-Jer Chen, M.D.; Ph.D. | National Taiwan University Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00154869 History of Changes |
| Other Study ID Numbers: | 921003, ML17862 |
| Study First Received: | September 8, 2005 |
| Last Updated: | August 10, 2007 |
| Health Authority: | Taiwan: Department of Health |
|
Patients with dual chronic hepatitis B and C |
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis C Hepatitis B, Chronic Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Hepadnaviridae Infections DNA 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 |