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Hepatitis Delta Infections in Hemophiliacs

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00005305
First received: May 25, 2000
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
To elucidate the role of hepatitis delta virus (HDV) in the development of chronic liver disease in patients with hemophilia.

Condition Intervention
Blood Disease
Hepatitis, Viral, Human
Liver Diseases
Hemophilia A
Other: No interventions - observational study

Study Type: Observational
Official Title: Prevalence and Consequences of Hepatitis Delta Virus Infection in Hemophiliacs

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Enrollment: 61
Study Start Date: September 1987
Study Completion Date: September 1991
Primary Completion Date: September 1991 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hemophilic individuals
Subjects receiving multiple blood products for treatment of hemophilia
Other: No interventions - observational study

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:

The study was conducted collaboratively within the seven hemophilia treatment centers which comprised the Southeastern Hemophilia Group. Upon entry into the study, patient data were collected on transfusion and factor concentrate therapy, age, race, type of hemophilia, sex, homosexuality, drug abuse and HTLV-III antibody status. Liver function was assessed noninvasively. Since available tests for HDV infection had limited sensitively and were not necessarily specific for HDV persistence, HDV RNA was detected in serum by molecular hybridization using cloned HDV cDNA and single-stranded RNA probes. Western blot analysis was used to assess antibody responses to HDV. A multifactorial analysis of clinical and virological data was conducted at the end of the first year of the study. Patients were reevaluated clinically and virologically at six month intervals to ascertain risk factors for acquisition of HBV and HDV infections, and to assess the prevalence and rate of progression of liver disease in each group. Follow-up of patients who had not been previously transfused, allowed an assessment of the efficacy of current control measures such as HBV immunization and use of heat-treated factor concentrates for prevention of viral infections in hemophiliacs.

Plans for extended follow-up of HDV-infected vs non-infected subjects were confounded by the unexpected emergence of human immunodeficiency virus infection in the hemophilic subjects who comprised the study population.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005305

Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Stanley M Lemon, MD University of North Carolina, Chapel Hill
  More Information

Publications:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00005305     History of Changes
Other Study ID Numbers: 3006  R01HL037974 
Study First Received: May 25, 2000
Last Updated: June 13, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis D
Hepatitis
Hepatitis A
Liver Diseases
Hemophilia A
Hepatitis, Viral, Human
Hematologic Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on December 06, 2016