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

Hepatitis C Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004804
• Other study ID #: 199/11964
• Secondary ID: TUMC-M1260
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2000
• Last updated: June 23, 2005
• Start date: August 1993

Study information

• Verified date: February 1997
• Source: Office of Rare Diseases (ORD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• interferon alfa

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	Tulane University School of Medicine