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

This study has been completed.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Tulane University School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004804

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 III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Interferon alfa-2a Interferon alfa-n1 Interferons

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

National Center for Research Resources (NCRR)

Tulane University School of Medicine

Investigators

Study Chair:

Anna S. F. Lok

Tulane University School of Medicine

More Information

No publications provided

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

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Immunologic Factors
Interferons
Rare Diseases
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Interferon-alpha
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances
Interferons
Physiological Effects of Drugs
Hepatitis, Viral, Human

Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon Alfa-2a

ClinicalTrials.gov processed this record on May 07, 2009