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| Sponsor: | InterMune |
|---|---|
| Information provided by: | InterMune |
| ClinicalTrials.gov Identifier: | NCT00084279 |
Purpose
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | AGHC-002 |
| Study First Received: | June 9, 2004 |
| Last Updated: | July 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00084279 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Hepatitis C Liver Pegylated Interferon Alpha Gamma |
Ribavirin Combination Nonresponder Pegasys PegIntron |
|
Antimetabolites Anti-Infective Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Interferon Type II Flaviviridae Infections Hepatitis, Chronic Immunologic Factors Antineoplastic Agents Ribavirin Physiological Effects of Drugs Hepatitis, Viral, Human Therapeutic Uses Growth Inhibitors Hepatitis C |
Angiogenesis Modulating Agents Interferon-alpha RNA Virus Infections Growth Substances Interferons Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Virus Diseases Hepatitis Digestive System Diseases Interferon Alfa-2a Hepatitis C, Chronic Interferon-gamma, Recombinant |