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Population demonstration project aiming for zero transmission of hepatitis B virus from mothers-to- child in Taizhou, Zhejiang Province

Project of blocking transmission of hepatitis B virus from mother to child in Taizhou

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017932
Enrollment
Unknown
Registered
2018-08-22
Start date
2018-11-15
Completion date
Unknown
Last updated
2018-11-05

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

Conditions

Hepatitis B

Interventions

Early medication group:This group of patients take TDF 300mg daily from 24W±7d, and stop the therapy at delivery.
Late medication group:This group of patients take TDF 300mg daily from 28W±7d, and stop the therapy at delivery.

Sponsors

the First Affiliated Hospital, Zhejiang University College of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) normal pregnancy status; 2) Aged at least 20 years; 3) HBsAg(+)and HBeAg(+); 4) HBV-DNA = 2 * 10^6 IU / ml in the middle and late pregnancy (= 17w); 5) The patient agrees to be included in the study and is willing to cooperate with the follow-up, including the collection of infant information and blood samples.

Exclusion criteria

Exclusion criteria: 1) Received any anti-hepatitis B virus treatment during pregnancy; 2) HIV or HCV antibody is positive; 3) Any degree of chronic renal dysfunction (urinary protein > 1 + or urinary protein quantification = 30 mg / l or CCr = 90 ml / min or urine glucose positive) CCr calculation using the Cockcroft-Gault formula; 4) Has a history of abnormal pregnancy (natural abortion, fetal defects) 5) ALT = 2 upper normal limit is normal before treatment in pregnancy; 6) Compensated or decompensated cirrhosis (APRI>2); 7) Has received immunosuppressive therapy or nephrotoxic drugs during pregnancy.

Design outcomes

Primary

MeasureTime frame
the rate of HBV transmission from mother to child;Maternal HBV-DNA declining rate;Mothers' kidney function;mothers' liver function;Newborn growth;Infants' growth;Medication compliance;Knowledge Attitude and Performance questionnaire about HBV ;

Countries

China

Contacts

Public ContactShigui Yang

the First Affiliated Hospital, Zhejiang University College of Medicine

yangshigui@zju.edu.cn+86 13605705640

Outcome results

None listed

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