Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C
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.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||August 1993|
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.
|Study Chair:||Anna S. F. Lok||Tulane University School of Medicine|