Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000580
First received: October 27, 1999
Last updated: November 25, 2013
Last verified: January 2000
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Drug: immunoglobulins, intravenous
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: November 1975
Study Completion Date: June 1986
Detailed 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.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

  Eligibility

Ages Eligible for Study:   up to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface antigen carriers.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Beasley RP, Stevens CE: Vertical Transmission of HBV and Interruption with Globulin, in Vyas GN, Cohen SN, Schmid R (eds.), Viral Hepatitis: A Contemporary Assessment of Etiology, Epidemiology, Pathogenesis and Prevention. Philadelphia, Franklin Institute Press, 1978, 333-345.

ClinicalTrials.gov Identifier: NCT00000580     History of Changes
Other Study ID Numbers: 300, P01HL009011-18A1
Study First Received: October 27, 1999
Last Updated: November 25, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hepatitis, Viral, Human
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014