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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 20, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

December 29, 2010

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Child HBsAg 6 mo[ Time Frame: 6 months after delivery ]

Serum status of HBsAg of the infants at 6 months old

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: treatment group
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
No Intervention: control group
control group receive no drug, only follow-up

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

360

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 31, 2021

Estimated Primary Completion Date

December 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

20 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Taiwan

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名