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Sponsors and Collaborators: |
Novartis Human Genome Sciences |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00759200 |
This study will evaluate the safety and efficacy of alb-interferon in adults with genotype 2 or 3 chronic hepatitis
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Drug: alb-interferon alfa 2b Drug: peg-interferon |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | An Open-Label, Randomized, Multicenter, Active-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of Albinterferon Alfa 2b Administered Every 4 Weeks Plus Ribavirin in Interferon Alfa-naïve Patients With Genotype 2/3 Chronic Hepatitis C |
Estimated Enrollment: | 525 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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alb-interferon arm 1: Experimental |
Drug: alb-interferon alfa 2b
900 mcg every 4 weeks
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alb-interferon arm 2: Experimental |
Drug: alb-interferon alfa 2b
1200 mcg every 4 weeks
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alb-interferon arm 3: Experimental |
Drug: alb-interferon alfa 2b
1500 mcg every 4 weeks
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alb-interferon arm 4: Experimental |
Drug: alb-interferon alfa 2b
1800 mcg every 4 weeks
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peg-interferon: Active Comparator |
Drug: peg-interferon
Peg-interferon alfa 2a: 180 mcg 1x per wk.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis Pharmaceuticals | +41 61 324 1111 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CABF656B2202 |
Study First Received: | September 23, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00759200 |
Health Authority: | Thailand: Food and Drug Administration; Taiwan: Department of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration; India: Drugs Controller General of India; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Italy: The Italian Medicines Agency; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Chronic hepatitis C genotype 2 genotype 3 albumin interferon alfa-2b alb-interferon |
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 |
Anti-Infective Agents RNA Virus Infections 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 |