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

This study has been completed.
Sponsor:
Collaborator:
Tulane University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004804
First received: February 24, 2000
Last updated: June 23, 2005
Last verified: February 1997
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: interferon alfa
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 57
Study Start Date: August 1993
Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004804

Sponsors and Collaborators
Tulane University School of Medicine
Investigators
Study Chair: Anna S. F. Lok Tulane University School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004804     History of Changes
Other Study ID Numbers: 199/11964, TUMC-M1260
Study First Received: February 24, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
hepatitis C
immunologic disorders and infectious disorders
rare disease
viral infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 22, 2014