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

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis B Virus Infection
• Intervention / Treatment: Drug: Tenofovir Alafenamide

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: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mei-Hwei Chang; Phone Number: 71701 +886-2-23123456; Email: changmh@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Ivy Chiou; Phone Number: 71737 +886-2-23123456; Email: ivyntuh@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment group; Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.	Drug: Tenofovir Alafenamide; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child HBsAg 6 mo	Serum status of HBsAg of the infants at 6 months old	6 months after delivery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 29, 2010
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (ACTUAL): October 3, 2018

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

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Herpesviridae Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: 201010078M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No