Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

Hepatitis B Virus Infection Clinical Trial

Official title:

Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03695029
• Other study ID #: 201010078M
• Status: Recruiting
• Phase: Phase 4
• Start date: December 29, 2010
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: Mei-Hwei Chang
• Phone: +886-2-23123456
• Email: changmh[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.

Description:

This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion criteria:

• Women aged 20-45 years in 28 to 32 weeks of pregnancy
• Positive HBsAg and HBeAg
• Serum viral load above 6 log10 IU/mL

Exclusion criteria:

• Major systemic disease of the mother or fetus
• Positive anti-HIV or anti-HCV
• Under treatment of antiviral therapy
• Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
• Pregnant woman whose amniocentesis reveals any genetic abnormality

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Virus Infection
• Herpesviridae Infections

Intervention

Drug:
• Tenofovir Alafenamide
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child HBsAg 6 mo	Serum status of HBsAg of the infants at 6 months old	6 months after delivery
Secondary	Child HBsAg 12 mo	Serum status of HBsAg of the infants at 12 months old	12 months after delivery
Secondary	Maternal ALT elevation	Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery	6 months after delivery
Secondary	Maternal HBeAg-seroconverion	HBeAg-seroconversion rate within 12 months after delivery	12 months after delivery
Secondary	Maternal renal	Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery	6 and 12 months post delivery
Secondary	Materna bone marker	Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery	6 and 12 months post delivery
Secondary	Children's growth	Children's growth: height (cm) in Z score at 6 and 12 months after birth	6 and 12 months after birth
Secondary	Children's growth	Children's growth: weight (kg) in Z score at 6 and 12 months after birth	6 and 12 months after birth