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Sponsors and Collaborators: |
Seoul National University Hospital Hoffmann-La Roche SciClone Pharmaceuticals |
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Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00291616 |
The purpose of this study is to determine the optimal treatment duration of antiviral therapy for chronic hepatitis B.
Condition | Intervention | Phase |
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Chronic Hepatitis B |
Drug: Pegylated Interferon-alpha2a Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Historical Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Controlled Trial of Combination Therapy for HBeAg Positive Chronic Hepatitis B: Comparing Thymosin Alpha 1 and Pegylated Interferon-alpha2a With Pegylated Interferon-alpha2a Alone. |
Enrollment: | 52 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Pegylated Interferon-alpha2a
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Drug: Pegylated Interferon-alpha2a
180 microgram s.c. injection weekly
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2: Active Comparator
Thymosin alpha1 & Pegylated Interferon-alpha2a
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Drug: Thymosin alpha1 & Pegylated Interferon-alpha2a
Pegylated interferon 180 microgram s.c. injection weekly Thymosin 1.6 mg s.c. injection twice per week
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Thymosin alpha1/interferon combination therapy has been known as an effective antiviral therapy for chronic hepatitis B. It is superior to interferon single therapy since the sustained viral response rate of combination therapy used to be about 70% compared with that of single interferon therapy(20%). Until now, the combination therapy including 6-month treatment of thymosin alpha1 has been as effective as 12-month treatment of thymosin alpha1. We hypothesized that thymosin alpha1 is an immune potentiator so, the shorter duration of thymosin alpha1 treatment might be as effective as the prolonged treatment duration.
In detail, we designed to perform this clinical study comparing the combination of pegylated interferon and thymosin alpha1 with pegylated interferon alone. Total treatment duration of both parallel groups will be 12 months, and the combination therapy will be lasted for the first 3 months followed by the next, ongoing pegylated interferon single therapy for 9 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of, Chongno-gu | |
Seoul National University Hospital | |
Seoul, Chongno-gu, Korea, Republic of, 110-744 |
Principal Investigator: | Jung H Yoon, M.D. | Seoul National University Hospital |
Responsible Party: | Seoul National University Hospital ( Won Kim ) |
Study ID Numbers: | 12-05-008 |
Study First Received: | February 13, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00291616 |
Health Authority: | Korea: Food and Drug Administration |
chronic hepatitis B, pegylated interferon, thymosin alpha |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Hepatitis, Chronic Interferons Hepatitis, Viral, Human Hepatitis Virus Diseases |
Thymalfasin Digestive System Diseases Hepatitis B, Chronic Hepatitis B Peginterferon alfa-2a DNA Virus Infections Interferon Alfa-2a |
Anti-Infective Agents Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Adjuvants, Immunologic Hepadnaviridae Infections |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |