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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C

Keywords

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hepatitis C immunologic disorders and infectious disorders rare disease viral infection

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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interferon alfa

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Anna S. F. Lok

Role: STUDY_CHAIR

Tulane University School of Medicine

Other Identifiers

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TUMC-M1260

Identifier Type: -

Identifier Source: secondary_id

199/11964