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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: interferon alfa

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004804

TUMC-M1260

199/11964

Details and patient eligibility

About

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.

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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