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Efficacy and safety of TAF vs TDF used in early and middle pregnancy with CHB who develop hepatitis during pregnancy: a multicenter prospective cohort study

Efficacy and safety of TAF vs TDF used in early and middle pregnancy with CHB who develop hepatitis during pregnancy: a multicenter prospective cohort study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093279
Enrollment
Unknown
Registered
2024-12-02
Start date
2024-12-02
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Chronic viral hepatitis B in the first and second trimesters

Interventions

Tenofovir:None
Tenofovir alafenol:None

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 20-40 years old; 3.HBsAg positive = 6 months; 4.ALT > 40 U/L at 0 to 24 weeks of pregnancy and antiviral therapy with TAF/TDF; 5.Voluntarily accept regular use of TAF/TDF 1 time per day until the end of labor or long-term use; 6.Good adherence;

Exclusion criteria

Exclusion criteria: 1.Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS; 2.Concomitant cirrhosis, liver cancer, or other chronic liver disease; 3.Patients with diseases of important organs such as heart, lungs, and kidneys; 4.Accompanied by autoimmune hepatitis, autoimmune diseases, hypertension, diabetes, thyroid disease; 5.Those who have complications in previous pregnancies; 6.Those who have had fetal or neonatal growth and development defects in previous pregnancies; 7.Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators; 8.History of anti-hepatitis B virus use within 1 year before pregnancy; 9.Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, and threatened abortion;

Design outcomes

Primary

MeasureTime frame
ALT;

Secondary

MeasureTime frame
Hepatitis B in half /HbsAg;HBV-DNA;Deformity rate;Pregnancy complications;Growth and development data;Mode of delivery;Liver imaging changes;

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