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Trial NCT00000580

Resource URI: http://static.linkedct.org/resource/trials/NCT00000580
linkedct:brief_title Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
linkedct:condition <http://static.linkedct.org/resource/condition/5858>
linkedct:condition <http://static.linkedct.org/resource/condition/5878>
linkedct:condition <http://static.linkedct.org/resource/condition/7332>
linkedct:criteria Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface antigen carriers.
linkedct:description BACKGROUND: A baseline study on the vertical transmission of hepatitis B virus in Taiwan revealed that 15 percent of all pregnant women were persistent carriers of hepatitis B antigen and that 40 percent of their new babies developed a protracted antigenemia during the first 6 months of life. The incidence of acute hepatitis, cirrhosis, and hepatoma was high in Taiwan, and patients with these disorders had a fivefold to sixfold higher prevalence of hepatitis B antigen than healthy persons. Given the important public health problems of this disease in Taiwan and the rest of the Third World, this trial sought to answer the important question of whether hepatitis B immune globulin with a high level of antibody against the antigen would be of utility in combating the problem. Two hundred and five babies were accepted into the study, which was actually conducted on Taiwan through a contract to the Community Blood Council of Greater New York. Only those babies born of mothers who had HBsAg complement fixation titers of 1:8 or greater were included in these studies. At birth, blood was obtained from the mothers and cord blood from the infants. Follow-up bloods were obtained from both the mother and baby when the infants were 1, 3, 6, 12, 24 and 36 months of age. In addition, all household family contacts were bled at least once during this period. DESIGN NARRATIVE: Randomized, double-blind, fixed sample. A total of 205 neonates were assigned to treatment with high-titer hepatitis B immune globulin, standard immune globulin, or albumin placebo within 72 hours of delivery.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 3 Years
linkedct:eligibility_minimum_age N/A
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000580
rdfs:label Trial NCT00000580
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000580
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 300
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000580>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/327>
linkedct:reference <http://static.linkedct.org/resource/reference/42627>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date November 1975
linkedct:study_design Prevention, Randomized, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
rdf:type linkedct:trials
linkedct:verification_date January 2000