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Sponsors and Collaborators: |
Beth Israel Deaconess Medical Center Schering-Plough |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00179413 |
In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.
Condition | Intervention | Phase |
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Hepatitis C Virus Advanced Fibrosis Cirrhosis |
Drug: PEG interferon Alfa-2b; Colchicine |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase IV Study of Long Term Peg-Intron for Patients Who Have Failed to Respond to Rebetron/Interferon With Advanced Fibrosis and Cirrhosis Secondary to Hepatitis C- The Copilot Trial |
Estimated Enrollment: | 800 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | December 2009 |
We are proposing a randomized trial of Peg-Intron 0.5mcg per kg weekly versus colchicine 0.6mg bid in prior non-responders to Interferon, Rebetron, PegIntron, or PegIntron & Ribavirin or any third agent such as Pegasys, CellCept, Amantadine with advanced fibrosis/cirrhosis. The specific aims of this proposal are to evaluate the role of long term Peg-Intron therapy on the natural history of patients with advanced chronic HCV infection with a primary focus on prevention of hepatic decompensation, progression of fibrosis and hepatoma development.
The study design will focus on 3 monthly clinical evaluation for decompensation of liver function, rigorous clinical screening for development of hepatocellular cancer and liver biopsies for determination of progression of liver fibrosis every second year.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
*Adult male or female, age 18 to 75 years
Previous treatment with at least three months of interferon or interferon / Ribavirin. Patients should have had no interferon for at least 2 months prior to enrollment.
Patients should have had a liver biopsy showing at least Stage 3 disease prior to being considered for this study. A baseline liver biopsy is necessary for inclusion in the study. Baseline liver biopsies can be performed within six months of entering the study.
In patients with cirrhosis and endoscopic evidence of portal hypertension, a biopsy within the last 2 years is acceptable as the baseline biopsy. For patients with established cirrhosis on liver biopsy and no portal hypertension, a biopsy within 12 months can be used as the baseline biopsy if it is available for evaluation by the Pathology core. All these patients will still require liver biopsy at 2 years and 4 years. The decision to biopsy at 2 and 4 years is also a clinical decision and in the presence of clinical progression or coagulopathy, or where there may be a risk from liver biopsy, the Investigator should call the PI, Dr. Afdhal for a waiver of biopsy. Patients with Ishak Stage 3 and 4 require a biopsy within 6 months of randomization.
Platelet count: For standard dose of PEG-Intron 0.5mcg/kg platelet count must be greater than 70,000. Patients with platelet count 50 - 70,000 can start at 0.25mcg/kg for weeks 0 - 4. If platelets fall to less than 30,000, stop treatment. If platelets remain > 50,000 at week 4, PEG-Intron can be increased to 0.5mcg/kg. Patients randomized to Colchicine with platelets 50,000 - 70,000 can be started at standard dose 0.6mg bid po with standard dose reduction.
HIV negative.
Exclusion Criteria:
Any cause of liver disease based on patient history and biopsy (where applicable) other than chronic hepatitis C including but not limited to:
In addition:
Preexisting psychiatric conditions, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt are excluded. Patients with a history of mild depression may enter the protocol if they meet the following eligibility criterion and are monitored more intensively.
Mild depression: to include either situational depression of a limited period or depressive symptoms, which do not significantly interfere with the patient's work or daily functions.
Any patient with an active manic element to his/her previous symptom complex will be excluded.
Any known pre-existing medical condition that could interfere with the patient's participation in and completion of the study such as:
Any other condition, which in the view of the investigator, would make the patient unsuitable for enrolment, or could interfere with the patient participating in and completing the protocol are included as well.
Principal Investigator: | Nezam H Afdhal, MD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 2001-P-000002 |
Study First Received: | September 10, 2005 |
Last Updated: | June 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00179413 |
Health Authority: | United States: Food and Drug Administration |
hepatitis C cirrhosis interferon colchicine |
Interferon-alpha Liver Diseases Fibrosis Interferons Hepatitis, Viral, Human Liver Cirrhosis Hepatitis Virus Diseases |
Digestive System Diseases Neoplasm Metastasis Peginterferon alfa-2b Colchicine Hepatitis C Interferon Alfa-2a Interferon Alfa-2b |
Anti-Infective Agents RNA Virus Infections Flaviviridae Infections Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Mitosis Modulators Antimitotic Agents |
Angiogenesis Inhibitors Gout Suppressants Antiviral Agents Pharmacologic Actions Pathologic Processes Therapeutic Uses Tubulin Modulators Growth Inhibitors Angiogenesis Modulating Agents Antirheumatic Agents |