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

Phase 4

• Conditions: Hepatitis B Virus Infection, Pregnancy
• Interventions: Drug: antiviral therapy

• Registration Number: NCT01312012
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-03-08
• Study First Posted: 2011-03-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-27
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The effectiveness and feasibility, using antiviral therapy	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.

Primary Outcome Measures

Name	Time	Method
Child-HBsAg	6 months after delivery	serum status of HBsAg of the infants at 6 months old( \>180 days).

Secondary Outcome Measures

Name	Time	Method
Maternal ALT elevation	delivery to 5 years after delivery	The extent (folds of upper limit of normal, ULN) of ALT elevation and duration.
Children bone growth	2-5 years after birth	comparisons of BAP levels(U/L) and bone density (DEXA) between control and treatment group
Child HBsAg	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.
Maternal HBV DNA	delivery to 5 years after delivery	Change of levels of HBV DNA (log IU/mL) from baseline
Children growth parameters	0-5 years after birth	body weight and length Z score according to age
Children HBV status	0-5 years after birth	HBsAg and anti-HBs positivity rates
Children serum biochemistry	0-5 years after birth	Rates of abnormal levels of serum ALT(U/L), creatinine (mg/dL) and calcium (mmol/L)
Maternal HBeAg seroconversion rate	delivery to 5 years after delivery	Maternal HBeAg seroconversion rate, the time of HBeAg (+) to convert to HBeAg(-) after delivery

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan