The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test

November 25, 2020 updated by: National Taiwan University Hospital

The Effectiveness and Feasibility of Using Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test and Follow-up Study

Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment.

A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Chien Nan Lee, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL

Exclusion Criteria:

  • major systemic disease
  • Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
  • Pregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus
  • Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
  • Pregnant woman whose amniocentesis reveals any genetic abnormality

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The effectiveness and feasibility, using antiviral therapy
Experimental: Subjects receive tenofovir disoproxil fumarate (TDF) oral use prior to delivery in pregnant women with positive serum HBeAg and HBsAg and high HBV DNA levels > 10^8copies / mL, to reduce the rate of mother to infant transmission of HBV infection, and also to monitor the safety of the therapy.
Drug: antiviral therapy
100-120 pregnant women seropositive for both HBeAg and HBsAg and with hepatitis B viral DNA level > 10 8 copies/mL. Among them, 55-65 pregnant women will receive TDF therapy 300 mg once daily, starting from the gestational age 30-32 (the 3rd trimester) until 4 weeks after delivery of the neonate under informed consent. The total treatment duration will be 3-4 months. Another 45-55 pregnant women with the same serum HBAg and HBsAg and HBV DNA status will be enrolled as the control group with no TDF therapy ( An open-labeled study)
No Intervention: Control
Subjects receive no intervention, but with blood tests for mothers and infants before and after delivery, as a comparative group to experimental arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child-HBsAg
Time Frame: 6 months after delivery
serum status of HBsAg of the infants at 6 months old( >180 days).
6 months after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child HBsAg
Time Frame: 12 months after birth
Serum HBsAg positivity of the infants at 12 months old, to see whether this child indeed becomes a chronic carrier of HBV.
12 months after birth
Children growth parameters
Time Frame: 0-5 years after birth
body weight and length Z score according to age
0-5 years after birth
Children HBV status
Time Frame: 0-5 years after birth
HBsAg and anti-HBs positivity rates
0-5 years after birth
Children serum biochemistry
Time Frame: 0-5 years after birth
Rates of abnormal levels of serum ALT(U/L), creatinine (mg/dL) and calcium (mmol/L)
0-5 years after birth
Maternal HBeAg seroconversion rate
Time Frame: delivery to 5 years after delivery
Maternal HBeAg seroconversion rate, the time of HBeAg (+) to convert to HBeAg(-) after delivery
delivery to 5 years after delivery
Maternal ALT elevation
Time Frame: delivery to 5 years after delivery
The extent (folds of upper limit of normal, ULN) of ALT elevation and duration.
delivery to 5 years after delivery
Maternal HBV DNA
Time Frame: delivery to 5 years after delivery
Change of levels of HBV DNA (log IU/mL) from baseline
delivery to 5 years after delivery
Children bone growth
Time Frame: 2-5 years after birth
comparisons of BAP levels(U/L) and bone density (DEXA) between control and treatment group
2-5 years after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Mei-Hwei Chang, PhD, National Taiwan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

March 8, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Actual)

November 27, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201010078M, 201507025RINC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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