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

Last updated: June 23, 2005
Sponsor: National Center for Research Resources (NCRR)
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT00004804
199/11964
TUMC-M1260
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 57
Study Start date:
August 01, 1993
Estimated Completion Date:

Study Description

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.