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A study on the safety of temporary tenofovir against maternal-infant transmission of HBV in patients with chronic HBV carriers

A study on the safety of temporary tenofovir against maternal-infant transmission of HBV in patients with chronic HBV carriers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015706
Enrollment
Unknown
Registered
2018-04-16
Start date
2018-09-04
Completion date
Unknown
Last updated
2019-09-30

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

Conditions

Chronic hepatitis B

Interventions

Case series:Stopped to observe

Sponsors

The Third People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Pregnant women with HBeAg positive chronic hepatitis b, aged between 20 and 50 years old, HBV DNA=2×105 IU/ml (or 6 log10 copies/ ml) before taking the drug, started oral administration of tenofovir divir (TDF) between 24 and 28 weeks during pregnancy and stopped taking the drug immediately after delivery.

Exclusion criteria

Exclusion criteria: Co-infection with hiv-1, or hepatitis c, or syphilis; Renal insufficiency; Liver cancer or liver insufficiency; Creatinine clearance (CLCr) 5 times the normal upper limit; Total bilirubin > 2 mg/dL;Albumin < 25mg/L; Threatened abortion; Ultrasound indicated fetal malformation; Being treated with nephrotoxic drugs, steroids, cytotoxic drugs, non-steroidal anti-inflammatory drugs or immunomodulators; Receiving an organ or bone marrow transplant; Severe liver, kidney, cardiovascular, pulmonary, or neurological diseases or immunocompromised diseases (including malignancies) were determined by the investigator.

Design outcomes

Primary

MeasureTime frame
liver function;HBV DNA load;HBV serological markers;

Countries

China

Contacts

Public ContactLiuqing Yang

The Third People's Hospital of Shenzhen

350281813@qq.com+86 13826552497

Outcome results

None listed

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