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Sponsors and Collaborators: |
National Taiwan University Hospital National Health Research Institutes, Taiwan National Science Council, Taiwan |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00117533 |
The treatment of choice for chronic hepatitis D is uncertain. The investigators hypothesize that pegylated interferon (IFN) alfa-2b in combination with ribavirin (RBV) may be effective in the treatment of chronic hepatitis D patients who are also infected by hepatitis B virus (HBV). The purpose of this study is to test this hypothesis. The investigators will use pegylated IFN alfa-2b in combination with RBV for the treatment of patients with dual chronic hepatitis D virus (HDV) and HBV infection. A 24-week course of combination therapy pegylated IFN+RBV will be used.
Condition | Intervention | Phase |
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Chronic Hepatitis B Chronic Hepatitis D |
Drug: pegylated IFN alfa-2b plus ribavirin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study to Evaluate the Efficacy and Safety of Pegylated Interferon Alfa-2b Plus Ribavirin in the Treatment of Patients With Dual Chronic Hepatitis B and Delta |
Estimated Enrollment: | 20 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pei-Jer Chen, M.D., Ph.D. | 886-2-23123456 ext 7072 | peijer@ha.mc.ntu.edu.tw |
Taiwan | |
National Taiwan University | Not yet 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. | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 |
Principal Investigator: | Pei-Jer Chen, M.D., Ph.D. | National Taiwan University Hospital |
Study ID Numbers: | 930904 |
Study First Received: | June 30, 2005 |
Last Updated: | May 24, 2006 |
ClinicalTrials.gov Identifier: | NCT00117533 |
Health Authority: | Taiwan: Department of Health |
chronic hepatitis B; chronic hepatitis delta; treatment; pegylated interferon alfa-2b; ribavirin |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis D, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Hepatitis B, Chronic Peginterferon alfa-2b Hepatitis B Hepatitis D DNA Virus Infections Interferon Alfa-2a Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs |
Hepadnaviridae Infections Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |