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Sponsored by: |
InterMune |
---|---|
Information provided by: | InterMune |
ClinicalTrials.gov Identifier: | NCT00084279 |
To evaluate the safety and tolerability of two different doses of Consensus Interferon-Alpha and Interferon Gamma-1b with or without ribavirin in patients with chronic hepatitis C who are non-responders to PEG-IFN-a 2a or PEG-IFN-a 2b plus ribavirin.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: Consensus Interferon-Alpha, Interferon Gamma-1b, Ribavirin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study |
Official Title: | Safety and Tolerability of Consensus Interferon-Alpha (CIFN) Plus Interferon Gamma-1b (IFN-γ 1b) With or Without Ribavirin (RBV) in the Treatment of Patients With Chronic Hepatitis C Who Are Non-Responders to PEG-IFN-a (2a or 2b) Plus RBV |
Enrollment: | 81 |
Study Start Date: | April 2004 |
Study Completion Date: | April 2006 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | AGHC-002 |
Study First Received: | June 9, 2004 |
Last Updated: | October 29, 2007 |
ClinicalTrials.gov Identifier: | NCT00084279 |
Health Authority: | United States: Food and Drug Administration |
Chronic Hepatitis C Liver Pegylated Interferon Alpha Gamma |
Ribavirin Combination Nonresponder Pegasys PegIntron |
Interferon-alpha Liver Diseases Interferon Type II Hepatitis, Chronic Interferons Ribavirin Hepatitis, Viral, Human Hepatitis |
Virus Diseases Digestive System Diseases Peginterferon alfa-2b Peginterferon alfa-2a Hepatitis C Interferon Alfa-2a Hepatitis C, Chronic Interferon-gamma, Recombinant |
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 |