Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Department of Veterans Affairs Minneapolis Veterans Affairs Medical Center Minnesota Veterans Research Institute InterMune |
---|---|
Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00211692 |
Data have suggested that consensus interferon (CIFN) has greater antiviral activity in vitro compared with interferon alfa-2a or alfa-2b. Several clinical studies also suggest that CIFN has greater antiviral activity in patients with genotype 1 hepatitis C infection, particularly if given as a daily injection. These data indicate that the use of a regimen of daily CIFN and ribavirin will lead to greater virologic response rates compared with pegylated interferon alfa-2b and ribavirin in patients with genotype 1 infection, with comparable adverse events. Emerging data indicate that HCV genotype 1 patients with a delayed virologic response to initial therapy may benefit from an extended duration of therapy. Therefore, the goals of this pilot study are to determine the tolerability and efficacy of daily CIFN plus ribavirin when given for 52 weeks or an extended duration of therapy. The target population will consist of “difficult-to-treat” patients, defined as having the following characteristics: genotype 1, a North American patient population, predominantly male gender, and no specific exclusions for pre-existing psychiatric or substance abuse co-morbidities.
Condition | Intervention | Phase |
---|---|---|
Chronic Hepatitis C |
Drug: consensus interferon (Interferon Alfacon-1) and ribavirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Prospective, Randomized Pilot Study of Daily Consensus Interferon Alfa (CIFN) and Ribavirin for 52 Weeks Vs. Extended Duration to 72 Weeks Based on Early Virologic Response for the Initial Treatment of Difficult-to-Treat Patients With Chronic Hepatitis C Genotype 1 |
Estimated Enrollment: | 192 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | September 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Chronic hepatitis C. This is defined as the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C PCR test and a positive HCV genotype test for genotype 1, and a liver biopsy (within the previous 5 years) that is compatible with chronic hepatitis. (Note: no requirement is made for the presence of abnormal transaminases. Patients with persistently normal transaminases are allowed if they meet the definition of chronic hepatitis C above). Liver biopsy data is required on at least 90% of enrolled patients to allow for the potential refusal of patients for the liver biopsy test. In the case of patients that have refused liver biopsies a clinical diagnosis of chronic hepatitis C is required. In the absence of a liver biopsy within five years the clinical diagnosis requires a history compatible with a chronic hepatitis C infection with the documentation of the presence of circulating hepatitis C virus by a positive hepatitis C PCR test and a positive HCV genotype test for genotype 1, and biochemical evidence of prior abnormal transaminases at two times covering a time span of at least 6 months.
2. Positive HCV RNA by PCR, Genotype 1, treatment naive 3. Age 18-65 years. 4. Patient must be able to give informed consent. 5. Eligible for interferon alfa and ribavirin-based antiviral treatment:
Compensated liver disease with the following laboratory results at entry:
Exclusion Criteria:
Patients with active or uncontrolled psychiatric disease including:
o patients who have had recent prior severe psychiatric disease, such as patients who were previously hospitalized with major depressive or bipolar or major psychotic disorder within the last 2 years, and patients who were previously hospitalized for suicide attempts within the last two years,
1) CNS trauma or active seizure disorders requiring medication. 2) Significant cardiovascular dysfunction within the past 12 months 3) Poorly controlled diabetes mellitus (in the opinion of the site PI). 4) Moderate or severe chronic pulmonary disease 5) Clinically significant immunologically mediated disease 6) Hemoglobinopathies (e.g., Thalassemia) or any other cause of hemolytic anemia.
7) Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy or CHILD-PUGH scores B or C.
8) Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids.
9) Hypersensitivity to interferon alfa or ribavirin 10) Known anti-HIV positive 11) Clinically significant retinopathy 12) Previous solid organ transplantation 13) Any condition that, in the opinion of the investigator, will prevent the patient from being compliant with study medications or appointments.
8. Patients who develop hepatic decompensation during the course of treatment. The PT/INR, total bilirubin, albumin will be repeated at the 24 week interval to allow for a re-calculation of the CHILD-PUGH score. Patients who have developed a score of 7 or greater (CHILD-PUGH class B or greater) be considered for discontinuation of the study.
Contact: Samuel B Ho, M.D. | 612-467-4109 | samuel.ho@med.va.gov |
Contact: Bashar Aqel, M.D. | 612-467-2386 | bashar.aqel@med.va.gov |
United States, Minnesota | |
VA Medical Center (in addition to multiple other sites) | Recruiting |
Minneapolis, Minnesota, United States, 55417 | |
Contact: Samuel B. Ho, M.D. 612-467-4109 samuel.ho@med.va.gov | |
Principal Investigator: Samuel B. Ho, M.D. |
Principal Investigator: | Samuel B. Ho, M.D. | Department of Veterans Affairs |
Study ID Numbers: | MVRI001 |
Study First Received: | September 13, 2005 |
Last Updated: | December 15, 2005 |
ClinicalTrials.gov Identifier: | NCT00211692 |
Health Authority: | United States: Food and Drug Administration |
Hepatitis C interferon alfa ribavirin interferon alfacon-1 antiviral therapy |
Interferon-alpha Interferon Type I, Recombinant Liver Diseases Hepatitis, Chronic Ribavirin Interferons Hepatitis, Viral, Human |
Hepatitis Virus Diseases Digestive System Diseases Hepatitis C Interferon alfacon-1 Interferon Alfa-2a Hepatitis C, Chronic |
Antimetabolites Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances |
Physiological Effects of Drugs Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |