NCT00000580

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 1975

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1975

Completed
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1986

Completed
13.4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

January 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Hepatitis BHepatitis, Viral, HumanLiver Diseases

Interventions

immunoglobulins, intravenousDRUG

Eligibility Criteria

AgeUp to 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Boy and girl infants, birth to 3 years, born to mothers who were hepatitis B surface antigen carriers.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    BACKGROUND

  • Stevens CE, Neurath RA, Beasley RP, Szmuness W. HBeAg and anti-HBe detection by radioimmunoassay: correlation with vertical transmission of hepatitis B virus in Taiwan. J Med Virol. 1979;3(3):237-41. doi: 10.1002/jmv.1890030310.

    PMID: 479860BACKGROUND

MeSH Terms

Conditions

Hepatitis BHepatitis, Viral, HumanLiver Diseases

Interventions

Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitisDigestive System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

November 1, 1975

Study Completion

June 1, 1986

Last Updated

November 26, 2013

Record last verified: 2000-01