Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women

NCT05853718 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IIT-20210825-0020-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.

Conditions

Chronic Hepatitis b; Tenofovir Alafenamide Fumarate

Keywords

pharmacokinetics; CHB; TAF; pregnancy; mother-to-child transmission

Outcome Measures

Primary Outcomes (3)

• Assessment on the pharmacokinetics of TAF and TFV in plasma of pregnant women

  When taking the last TAF before delivery , 2ml of drug-containing blood was collected from the upper extremity veins at 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24h after taking TAF. Blood drug concentration at each time point was calculated according to standard curve.

  The day before delivery

• Rate of mother-to-child transmission of HBV

  Testing for HBsAg in the infants between 7 and 12 months of age.

  During 7-12 months after birth

• Rate of birth defect of infants

  The proportion of infants with the aforementioned abnormalities discovered during the study period

  From the date of birth to age of 28 weeks

Secondary Outcomes (3)

• Reduction of HBV DNA levels at delivery

  At delivery

• Drug concentration of TAF and TFV in breast milk after drug withdrawal

  Immediately after breast milk is available and last for 5 days

• Concentrations of TAF and TFV in infant urine and plantar blood

  Within 72 hours of birth

Study Arms (1)

TAF antiviral therapy group

EXPERIMENTAL

Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) from week 28-32 of gestation until delivery

Drug: Tenofovir Alafenamide Tablets

Interventions

Tenofovir Alafenamide Tablets DRUG

Take 25mg TAF daily from week 28-32 of gestation until delivery

Also known as: TAF

TAF antiviral therapy group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant woman is eligible for this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \>200 000 IU/mL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent.

You may not qualify if:

• Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \<50ml/min and urine protein test positive (\>300mg/L); Fetal malformations detected by B-ultrasound during pregnancy; ALT \> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \< 25 g/L.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhiyuan Ma, PhD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

• Siying Li, MD

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jin, MD

CONTACT

13372517879; jinjie0429@163.com

Zhiyuan Ma, PhD

CONTACT

18858273870; zhiyuan_ma@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: May 11, 2023
• Study Start: May 6, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)