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Phase III Randomized Study of High vs Standard Dose of Interferon alfa for Chronic Hepatitis C



Phase III Randomized Study of High vs Standard Dose of Interferon alfa for Chronic Hepatitis C

For Condition: Hepatitis C
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Tulane University School of Medicine
Synopsis: OBJECTIVES: I. Determine whether the initial response to interferon alfa (IFN-A) can be increased by starting at a dose of 5 MU three times a week in patients with chronic hepatitis C. II. Determine whether patients who had normalized alanine aminotransferase (ALT) levels can maintain normal ALT during stepwise dose reduction from 5 MU to 3 MU to 1.5 MU.
Details: PROTOCOL OUTLINE: Patients are randomly assigned to 1 of 2 treatment groups in a 2:1 ratio. The first group is treated with high-dose interferon alfa (IFN-A) administered subcutaneously twice a week for 12 weeks. If the alanine aminotransferase (ALT) level has normalized, the IFN-A dose is decreased in a stepwise fashion. If the ALT level decreases by more than 50%, IFN-A is continued at the same dose until week 24 or the ALT normalizes. If the ALT level decreases by less than 50%, treatment is discontinued. The second group is treated with standard-dose IFN-A administered subcutaneously twice a week for 24 weeks.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Biopsy-proven chronic hepatitis Anti-hepatitis C virus positive Hepatitis B surface antigen negative - No decompensated cirrhosis --Prior/Concurrent Therapy-- - No concurrent immunosuppressives At least 1 year since interferon --Patient Characteristics-- - Hepatic: No other cause of liver disease - Other: Not HIV positive
Total Enrollment: 57

Location and Contact Information:

Overall Study Official:
AnnaF. Lok,  Study Chair,  Tulane University School of Medicine


Additional Information:
Study ID Numbers:  199/11964;  TUMC-M1260
Study Start Date: August 1993
Record last reviewed: February 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004804

Other Hepatitis C Studies:
1. Treatment of Hepatitis C in Hemophilic Patients with HIV

2. Immune Response to Hepatitis C Virus

3. Interleukin-2 (IL-2), Pegylated Interferon (PEG-IFN alfa-2b), and Ribavirin (RBV) Treatment in Patients with Hepatitis C and HIV Coinfection

4. Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C with and without Kidney Disease

5. A Study to Evaluate the Effects of Anti-HIV Drugs in HIV-Positive Patients Who Also Have Hepatitis C Infection

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