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Clinical study on the efficacy and safety of Tenofovir alafenamide Fumarate for preventing mother-to-infant transmission of hepatitis B virus in pregnant women with high viremia

Clinical study on the efficacy and safety of Tenofovir alafenamide Fumarate for preventing mother-to-infant transmission of hepatitis B virus in pregnant women with high viremia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900028207
Enrollment
Unknown
Registered
2019-12-15
Start date
2019-12-17
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

chronic hepatitis B

Interventions

The group of Tenofovir alafenamide Fumarate:Tenofovir alafenamide Fumarate
the group of tenofovir:Tenofovir Disoproxil

Sponsors

The Seventh Affiliated Hospital, Sun Yet-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. The pregnant women had serum HBV DNA load higher than 10^6 copies/mL normal ALT and positive serum HBsAg and HBeAg before the treatment; 2. Ultrasound measurements performed during the 2nd. trimester showed no structural anomalies of the fetus without threatened abortion; 3. No alcohol/ smoking abuse or history; 4. No hypertensive disorders and diabetes mellitus before pregnancy.

Exclusion criteria

Exclusion criteria: 1. The pregnant women had other viral diseases or complications (such as hepatitis A, C, D, E and HIV infection); 2. The pregnant women had serious hepatic diseases, liver cirrhosis and or hepatic carcinoma and so on; 3. Other drugs (such as immunologic drugs,cytotoxic drugs or steroids) were taken during the period of pregnancy; 4. Husband with HBV infection.

Design outcomes

Primary

MeasureTime frame
serum marker for heptitis B;the level of HBV-DNA;serum biochemical test;Biometric data of the fetus under the ultrasound measurement;biometric data of the newborn;

Countries

China

Contacts

Public ContactYoupeng Chen

Department of Infectious Diseases, the Seventh Affiliated Hospital, Sun Yet-Sen University

youpeng.chen@163.com+86 13710675157

Outcome results

None listed

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