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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00686790 |
The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 ug/kg/wk administered for 52 weeks in previously untreated subjects coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.
Condition | Intervention | Phase |
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Hepatitis D, Chronic Hepatitis B, Chronic |
Biological: Peginterferon alfa-2b (SCH 54031) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open Label, Uncontrolled, Study to Assess the Response of Peg-Intron in naïve Patients With Chronic Hepatitis B and D co-Infection |
Enrollment: | 67 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Biological: Peginterferon alfa-2b (SCH 54031)
Peginterferon alfa-2b 1.5 ug/kg/wk SC for 52 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P04603 |
Study First Received: | May 27, 2008 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00686790 |
Health Authority: | Romania: National Medicines Agency |
Hepatitis D Hepatitis B |
Interferon-alpha Liver Diseases Hepatitis, Chronic Interferons Hepatitis D, Chronic Hepatitis, Viral, Human Hepatitis Virus Diseases |
Digestive System Diseases Hepatitis B, Chronic Hepatitis B Peginterferon alfa-2b Hepatitis D DNA Virus Infections Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents RNA Virus Infections Antineoplastic Agents Growth Substances Therapeutic Uses Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Antiviral Agents Hepadnaviridae Infections Pharmacologic Actions |