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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00371761 |
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the selection criteria will be randomly assigned 1:1 to (1) once-a-week, subcutaneous Peg-Intron (1.5 mg/kg body weight) or (2) oral adefovir 10 mg daily. The treatment phase will be 24 weeks for Peg-Intron and 48 weeks for adefovir. All subjects completing the assigned treatment phase will be followed up for an additional 48 weeks for Peg-Intron and 24 weeks for adefovir as observation phase. The primary objective is to establish the efficacy profile of Peg-Intron. Secondary objectives are to compare the efficacy profile of Peg-Intron with that of adefovir, compare efficacy of Peg-Intron in lamivudine-naïve and lamivudine-experienced subjects, and to establish the safety profile of Peg-Intron in treating patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B.
Condition | Intervention | Phase |
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Hepatitis B, Chronic |
Drug: Pegylated interferon alfa-2b Drug: Adefovir dipivoxil |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open-Label, Randomized, Comparative Study With Peg-Intron vs. Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan |
Estimated Enrollment: | 160 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental
Peg-Intron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
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Drug: Pegylated interferon alfa-2b
Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks
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Group B: Active Comparator
Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
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Drug: Adefovir dipivoxil
10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hepatitis B virus (HBV) replication and hepatitis documented by:
Exclusion Criteria:
Taiwan | |
Investigational Site 1 | |
Taipei, Taiwan, 100 | |
Investigational Site 2 | |
Taipei, Taiwan, 114 | |
Investigational Site 3 | |
Taiwan, Taiwan, 333 | |
Investigational Site 6 | |
Tainan, Taiwan, 704 | |
Investigational Site 5 | |
Taichung, Taiwan, 404 | |
Investigational Site 4 | |
Changhua, Taiwan, 500 |
Responsible Party: | Schering-Plough ( Bryan Wahking, MD - Medical Director, Taiwan Country Operations ) |
Study ID Numbers: | P04498 |
Study First Received: | August 31, 2006 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00371761 History of Changes |
Health Authority: | Taiwan: Department of Health |
Hepatitis B virus Interferon Alfa-2b |
Interferon-alpha Liver Diseases Immunologic Factors Hepatitis, Chronic Interferons Hepatitis, Viral, Human Angiogenesis Inhibitors Antiviral Agents Reverse Transcriptase Inhibitors Hepatitis Virus Diseases |
Digestive System Diseases Anti-Retroviral Agents Hepatitis B, Chronic Hepatitis B Peginterferon alfa-2b Adefovir dipivoxil DNA Virus Infections Interferon Alfa-2a Adefovir Interferon Alfa-2b |
Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Hepatitis, Chronic Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Hepatitis, Viral, Human Hepadnaviridae Infections Reverse Transcriptase Inhibitors Anti-Retroviral Agents Hepatitis B, Chronic Therapeutic Uses Hepatitis B Growth Inhibitors |
Angiogenesis Modulating Agents Nucleic Acid Synthesis Inhibitors Interferon-alpha Growth Substances Interferons Enzyme Inhibitors Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Peginterferon alfa-2b DNA Virus Infections Adefovir dipivoxil |