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

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ClinicalTrials.gov Identifier: NCT00004804
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Tulane University School of Medicine
Information provided by:
Office of Rare Diseases (ORD)

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.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: interferon alfa Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 57 participants
Primary Purpose: Treatment
Study Start Date : August 1993

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U.S. FDA Resources





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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004804     History of Changes
Other Study ID Numbers: 199/11964
TUMC-M1260
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 1997

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 C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs