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Clinical Trials/NCT00005305
NCT00005305CompletedNot Applicable

Prevalence and Consequences of Hepatitis Delta Virus Infection in Hemophiliacs

University of North Carolina, Chapel Hill0 sites61 target enrollmentStarted: May 26, 2000Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
61

Study Overview

Brief Summary

To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver disease in patients with hemophilia.

Detailed Description

BACKGROUND:

Patients with classical hemophilia (hemophilia A) and Christmas disease (hemophilia B) were exposed to many hepatotropic viruses during the course of their therapy. Severe chronic hepatitis among these patients was most likely related to persistent infection with non-A, non-B hepatitis virus, hepatitis B virus, or delta hepatitis virus, a defective RNA virus which is dependent upon coinfection with HBV for essential helper functions. Carriers of HBV could contract an acute delta hepatitis infection that was invariably more severe than the illness caused by HBV alone. The morbidity and mortality of delta hepatitis infection was remarkably high. Transmission of the delta hepatitis agent appeared to follow the same routes of transmission as HBV. Direct parenteral inoculation was the classic mode of transmission of HBV which suggested a similar mode of transmission for delta hepatitis.

In 1986, hemophiliacs treated with commercial concentrates of coagulation factors prepared from pools of plasma were at great risk to contract delta hepatitis infection. About 50 percent of these patients had delta hepatitis virus antibodies. Also, studies of small cohorts indicated that hepatitis delta infection was a major cause of chronic liver disease and cirrhosis. Therefore, there was a critical need to evaluate the frequency and effect of hepatitis delta infection in hemophiliacs, comparing those with presumed chronic non-A, non-B hepatitis, chronic hepatitis B alone, and combined chronic delta and HBV infections.

The project was awarded in response to a Request for Applications issued in 1986 on The Prevalence and Consequences of Hepatitis Delta Infection in Hemophiliacs. The concept for the initiative originated in the Blood Resources Working Group of the Blood Diseases and Resources Advisory Committee and was approved by The National Heart, Lung, and Blood, Advisory Council in February 1985.

DESIGN NARRATIVE:

Study Design

Study Type
Observational

Eligibility Criteria

Ages
— to 100 Years (Child, Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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