Clinical cohort study for maternal-infant blockade in pregnant women with hepatitis B based on Tenofovir alafenamide Fumarate tablets (TAF) and Tenofovir Disoproxil Fumarate Tablets (TDF)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR1900024195

Enrollment

Unknown

Registered

2019-06-29

Start date

2019-06-29

Completion date

Unknown

Last updated

2019-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatitis B

Interventions

TAF group: Tenofovir alafenamide Fumarate tablets

TDF group:Tenofovir Disoproxil Fumarate Tablets

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Age between 20-35 years old, 24-28 weeks during pregnancy; 2. HBsAg positive, HBeAg positive, and duration greater than 6 months, HBVDNA> 2×10^6 IU/mL; 3. Good clinical compliance.

Exclusion criteria

Exclusion criteria: (1) Concomitant infection with chronic hepatitis viruses such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, human immunodeficiency virus, cytomegalovirus, and Epstein-Barr virus; (2) Combined with other liver diseases, such as autoimmune liver disease, alcoholic liver disease, etc.; (3) Taking immunomodulatory agents, cytotoxic drugs or hormonal drugs during pregnancy; (4) Four-dimensional ultrasonography showed fetal malformation; (5) Combining chronic diseases such as cardiovascular and urinary systems; (6) Combined malignant tumors.

Design outcomes

Primary

Measure	Time frame
Virological response;	—

Secondary

Measure	Time frame
Neonatal growth and development;	—

Countries

China

Contacts

Public ContactBaijun Li

The Sixth People's Hospital in Shenyang

lbj890630@163.cm+86 18640348525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026