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A prospective study for the efficacy and safety of Telbivudine in hepatitis B virus infected pregnant woman to prevent mother-child transmission.

A prospective study for the efficacy and safety of Telbivudine in hepatitis B virus infected pregnant woman to prevent mother-child transmission.

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-PRC-11001541
Enrollment
Unknown
Registered
2011-08-19
Start date
2008-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Hepatitis B virus (HBV) infection is a serious clinical problem.In the Asia-Pacific region, the mother-to-child transmission of HBV from hepatitis B surface antigen (HBsAg)-positive mothers to their i

Interventions

control:All infants were vaccinated with HBV vaccine 20mg(within 12 hours of birth, at week 4, and at week 24) and 200 IU of HBIg within 2h of birth and in 15 days or 1 month.
Telbivudine:Cases received telbivudine 600mg per day from week 24-32 of gestation. All infants were vaccinated with HBV vaccine 20mg(within 12 hours of birth, at week 4, and at week 24) and 200 IU of

Sponsors

Institute for Infectious Diseases, Southwest Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: HBeAg+HBV DNA levels>1000000copies/mL mothers received telbivudine 600 mg/day from week 24-32 of gestation.

Exclusion criteria

Exclusion criteria: Pregnant woman whose HBVDNA viral load is low than 1000000 copies/ml.

Design outcomes

Primary

MeasureTime frame
HBV DNA and HBV Marker levels in the peripheral blood of mothers during they were received telbivudi;HBV DNA and HBV Marker levels in the peripheral blood of infants before 36 months.;

Secondary

MeasureTime frame
Secondary efficacy assessments included the liver;

Countries

China

Contacts

Public ContactProf Yuming Wang
wym417@163.com+86 23 68754858

Outcome results

None listed

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