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Prospective RCT study on the efficacy and safety of TAF vs TDF in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women

Prospective RCT study on the efficacy and safety of TAF vs TDF in early and middle pregnancy antiviral therapy for chronic hepatitis B pregnant women

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094099
Enrollment
Unknown
Registered
2024-12-17
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Pregnancy with chronic viral hepatitis B

Interventions

TAF antiviral group:TAF
TDF antiviral group:TDF

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.female; 2.Between 20 and 40 years old; 3.HBsAg positive =6 months; 0-24 weeks of pregnancy in accordance with the 2022 China Guidelines for Chronic Hepatitis B antiviral standards Use TAF/TDF antiviral (including but not limited to elevated transaminase, cirrhosis, liver fibrosis, hepatitis B extrahepatic manifestations, etc.); 4.Voluntarily receive TAF/TDF regularly once a day until the end of delivery or long-term use; 5.Good compliance;

Exclusion criteria

Exclusion criteria: 1.Accompanied by viral hepatitis A, C, E or other hepatitis virus infection or AIDS; 2.Accompanied by cirrhosis, liver cancer or other chronic liver disease; 3.Accompanied by heart, lung, kidney and other important organ diseases; 4.Accompanied by autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, thyroid disease; 5.Those with complications from previous pregnancies; 6.Fetal or neonatal growth and development defects in previous pregnancies; 7.Past or current use of nephrotoxic drugs, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators; 8.Ultrasound before medication indicated fetal malformation, fetal development abnormality, placental abnormality, and threatened abortion; 9.Failed to return for regular follow-up visits as planned;

Design outcomes

Primary

MeasureTime frame
HBsAg, HBeAg;HBV-DNA;Deformity rate;Complications of pregnancy;Liver function;HBV-DNA;

Secondary

MeasureTime frame
Growth and development data;Liver function;HBV-DNA;

Countries

China

Contacts

Public ContactXingfei Pan

The Third Affiliated Hospital of Guangzhou Medical University

673554097@qq.com+86 20 81292826

Outcome results

None listed

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