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Study 8 of 929 for search of: | Australia, Victoria |
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Sponsors and Collaborators: |
Human Genome Sciences Novartis |
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Information provided by: | Human Genome Sciences |
ClinicalTrials.gov Identifier: | NCT00402428 |
This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa 2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 1 who are IFNa treatment naive.
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: albumin interferon alfa-2b Drug: peginterferon alfa-2a Drug: Ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study to Evaluate the Efficacy and Safety of Albumin Interferon Alfa-2b in Combination With Ribavirin Compared With Peginterferon Alfa-2a in Combination With Ribavirin in Interferon Alfa Naive Subjects With CHC Genotype 1. ACHIEVE-1 |
Estimated Enrollment: | 1290 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
180 mcg PEG-IFNx2a every 1 week (48 doses) + Ribavirin 1000 or 1200 mg/day
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Drug: peginterferon alfa-2a
180 mcg once a week for 48 weeks
Drug: Ribavirin
1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg) |
2: Experimental
900 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
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Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks
Drug: Ribavirin
1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg) |
3: Experimental
1200 mcg alb-IFN every 2 weeks (24 doses)+ Ribavirin 1000 or 1200 mg/day
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Drug: albumin interferon alfa-2b
900 mcg or 1200mcg every two week for 48 weeks
Drug: Ribavirin
1000 mg/day(for subjects <75kg) or 1200 mg/day (for subjects =,> 75kg) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Study Director: | Medical Monitor | Human Genome Sciences, Inc |
Responsible Party: | Human Genome Sciences ( Patrick Cronin ) |
Study ID Numbers: | HGS1008-C1060, ACHIEVE-1 |
Study First Received: | November 20, 2006 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00402428 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Austria: Agency for Health and Food Safety; Austria: Ethikkommission; Canada: Ethics Review Committee; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; France: National Consultative Ethics Committee for Health and Life Sciences; Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices; India: Institutional Review Board; Israel: Ministry of Health; Italy: Ethics Committee; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Poland: Ministry of Health; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Switzerland: Ethikkommission; Switzerland: Swissmedic; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee; United States: Food and Drug Administration; United States: Institutional Review Board |
Chronic Hepatitis C Hepatitis C CHC HepC |
Genotype 1 Hepatitis HCV |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon Alfa-2b |
Antimetabolites Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Flaviviridae Infections Immunologic Factors Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |