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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: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00084279 History of Changes |
| Other Study ID Numbers: | AGHC-002 |
| Study First Received: | June 9, 2004 |
| Last Updated: | July 1, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Hepatitis C Liver Pegylated Interferon Alpha Gamma |
Ribavirin Combination Nonresponder Pegasys PegIntron |
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferon-alpha Interferon Alfa-2a |
Interferon-gamma Interferon-gamma, Recombinant Interferons Ribavirin Interferon alfacon-1 Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |