Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000580
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 18 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 QueryViewReport QVR System
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 18 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 QueryViewReport QVR System
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL009011-18A1 | NIH | None | httpsreporternihgovquickSearchP01HL009011-18A1 |