|
Delta Hepatitis and Liver Disease in Hemophiliacs Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Delta Hepatitis and Liver Disease in Hemophiliacs conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Delta Hepatitis and Liver Disease in Hemophiliacs Clinical research trials and Delta Hepatitis and Liver Disease in Hemophiliacs medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Delta Hepatitis and Liver Disease in Hemophiliacs. Delta Hepatitis and Liver Disease in Hemophiliacs Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Delta Hepatitis and Liver Disease in Hemophiliacs clinical trial. Participants frequently get the best healthcare available for their Delta Hepatitis and Liver Disease in Hemophiliacs condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Delta Hepatitis and Liver Disease in Hemophiliacs  Delta Hepatitis and Liver Disease in Hemophiliacs
Delta Hepatitis and Liver Disease in Hemophiliacs
For Condition: Hepatitis, Viral, Human,Hemophilia A,Blood Disease,Liver Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the prevalence of hepatitis delta virus (HDV) in a large cohort of hemophiliacs and to elucidate the role of HDV in the development and progression of liver disease in this population.
Details: 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. 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 in order to obtain data on the natural history of chronic liver disease, comparing those with presumed chronic non-A,non-B hepatitis B alone, and combined chronic delta and HBV infections. This grant 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: Both a prevalence study and a longitudinal study were conducted at several centers. In the prevalence study, active hepatitis delta viral infection was established by non-invasive serologic techniques such as hepatitis delta virus RNA/cDNA probes to detect hepatitis delta virus RNA and an immunoblotting method to detect hepatitis delta antigen. These tests avoided the need for liver biopsies to verify infection. In the longitudinal study, patients were assigned to a core or auxiliary groups with those in the core group sampled every six months for biochemical evidence of liver disease and those in the auxiliary group once a year. Serogroups 0,3,5, and 6 and other participants with evidence of delta hepatitis infection were assigned to the core group. Those patients who were immune to hepatitis B virus but were anti-hepatitis delta virus positive were assigned two controls, matched by center, age, sex, and hemophilia diagnosis and severity, from serogroups 5 who were without evidence of hepatitis delta virus infection. Thus, the role of delta virus infection in liver disease in hepatitis delta virus immune patients was evaluated. Follow-up continued for four years.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 3005;
Study Start Date: September 1986
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005304
Other Liver Diseases Studies:
1. Transfusion Medicine/Hemostasis Clinical Research Network
2. Delta Hepatitis and Liver Disease in Hemophiliacs
3. Prevention of Cerebral Infarction in Sickle Cell Anemia - Comprehensive Sickle Cell Center
4. Vietnam Era Twin (VET) Registry
5. Epidemiology and Immunology of Hemophilia A Inhibitors
Related Studies:
Other Liver Diseases Clinical Trials
Other Clinical Trials
Other Clinical Trials
Delta Hepatitis and Liver Disease in Hemophiliacs
|
|
|
|
|
|
|
|
