Phase III Randomized Study of High Vs Standard Dose of Interferon Alfa for Chronic Hepatitis C - Full Text View

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

This study has been completed.

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-n1 Interferon alfa-2a Interferon alfa-2b 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

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

Interferons

Rare Diseases

Hepatitis, Viral, Human

Hepatitis

Virus Diseases

Digestive System Diseases

Hepatitis C

Interferon Alfa-2a

Hepatitis C, Chronic

Interferon Alfa-2b

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Flaviviridae Infections

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Antiviral Agents

Angiogenesis Inhibitors

Pharmacologic Actions

Therapeutic Uses

Angiogenesis Modulating Agents

Growth Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008