Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: Tulane University School of Medicine
• Treatments: Interferon-alpha; Interferons

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