Prevention for Mother-to-infant Transmission of HBV

NCT02312531 | Completed DMC

• 1 other identifier: 2012ZX10002007-001-001 -1
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this study, HBV-infected pregnant women were divided into two groups, those who received and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed both the level and distribution of HBIG in placentas. The protective mechanism of HBIG administrated during pregnancy was explored.

Conditions

HBV

Keywords

HBV; Intrauterine infection; hepatitis B immunoglobulin; immune barrier; virus replication; placenta

Outcome Measures

Primary Outcomes (2)

• HBV infection of infants

  HBV DNA and HBsAg positive at the age of 1 year old

  one year

• Histopathological changes in placenta

  Immunohistochemical staining of HBsAg, HBIG and CD68

  at delivery

Secondary Outcomes (2)

• Serum HBV markers titers、HBV DNA load and liver function changes

  at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation

• Adverse events

  at weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40 of gestation, at delivery, at the age of 7 and 12 months of infants

Study Arms (2)

HBIG group

EXPERIMENTAL

Mothers in HBIG group received 'Hepatitis B immunoglobulin' (HBIG 200 IU, S20023028, Hualan Biological Engineering Inc.) injection at gestational weeks 20, 24, 28, 32, 34, 36, 38, 39, and 40.

Drug: Hepatitis B immunoglobulin

Control group

NO INTERVENTION

Mothers in control group had no HBIG injection during pregnancy.

Interventions

Hepatitis B immunoglobulin DRUG

Hepatitis B immunoglobulin 200 IU injection at gestational week 20, 24, 28, 32, 34, 36, 38, 39, and 40 in HBIG group mothers.

Also known as: HBIG

HBIG group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HBsAg positive for more than 6 months, gestational age less than 20 weeks

You may not qualify if:

• infection with toxoplasmosis, syphilis, parvovirus B19, rubella, cytomegalovirus, herpes, hepatitis C, HIV, or other viruses; obstetric diseases such as pregnancy-related hypertension, placental abruption, threatened miscarriage, and others.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

MeSH Terms

Interventions

hepatitis B hyperimmune globulin

Study Officials

• Tianyan Chen, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xi'an Jiaotong University College of Medicine

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 9, 2014
• Study Start: May 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12