NCT00004804

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at below P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1993

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2000

Completed
Last Updated

June 24, 2005

Status Verified

February 1, 1997

First QC Date

February 24, 2000

Last Update Submit

June 23, 2005

Conditions

Hepatitis C

Keywords

hepatitis Cimmunologic disorders and infectious disordersrare diseaseviral infection

Interventions

interferon alfaDRUG

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis CImmune System DiseasesCommunicable DiseasesRare DiseasesVirus Diseases

Interventions

Interferon-alpha

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsInfectionsHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Anna S. F. Lok

    Tulane University School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 24, 2000

First Posted

February 25, 2000

Study Start

August 1, 1993

Last Updated

June 24, 2005

Record last verified: 1997-02