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Study on the safety of breast-feeding in patients who received Tenofovir treatment to reduce maternal to child transmission of chronic hepatitis B virus

Study on the safety of breast-feeding in patients who received Tenofovir treatment to reduce maternal to child transmission of chronic hepatitis B virus

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100044877
Enrollment
Unknown
Registered
2021-03-31
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Block between mother and infant

Interventions

breast feeding group: Tenofovir treatment
artificial feeding group: Tenofovir treatment

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1.Deliverable infants of chronic hepatitis B pregnant women with HBsAg positive >=6 months; 2.Mothers need to continue oral tenofovir treatment after delivery; 3.Before delivery, the mother had five items of hepatitis B, HBV-DNA quantification, genotype, HBV-DNA sequence, liver function, blood routine, B-ultrasound of liver and gallbladder, and the relevant information was complete; 4.In the obstetrics department of our hospital, they can continue to follow up the mother and child according to the program requirements, and sign the informed consent, and their compliance is good.

Exclusion criteria

Exclusion criteria: 1.Complicated with HCV, HIV, HDV, HEV Treponema pallidum infection; 2.Diagnosed or suspected hepatocellular carcinoma or other malignant tumors; 3.Long-term use of hormones or immunosuppressants; 4.Allergic history to nucleoside analogues; 5.Prenatal diagnosis of fetal congenital malformations; 6.Severe diseases of pregnant women with other organs affect follow-up compliance of patients. 7.Creatinine clearance rate (CLCr) < 100 mL/min (Cockcroft-Gault method); 8.Low phosphorus and hypocalcemia.

Design outcomes

Primary

MeasureTime frame
bone mineral density;

Secondary

MeasureTime frame
physical development;adverse events;

Countries

China

Contacts

Public ContactZhu Yunxia

Beijing Youan Hospital, Capital Medical University

zyxno7@163.com+86 10 83997152

Outcome results

None listed

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