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Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission

NCT00939068 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2009-10-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of Telbivudine in pregnancy for the prevention of HBV perinatal transmission in highly viraemic mothers.

Conditions

  • Chronic Hepatitis B, Gestation

Interventions

DRUG

Telbivudine

Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.

BIOLOGICAL

engineered HB vaccine

All the newborns in control group are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20 ug respectively at age of 0, 1 and 6 months.

Sponsors & Collaborators

  • Southeast University, China

    lead OTHER

Principal Investigators

  • Wei Zhao, P.H.D · the Second Affiliated Hospital of Southeast University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-07-31
Completion
2010-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00939068 on ClinicalTrials.gov