Efficacy and Safety Study of Telbivudine to Prevent Perinatal Transmission
NCT ID: NCT00939068
Last Updated: 2009-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
180 participants
INTERVENTIONAL
2008-02-29
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telbivudine
Drug administration and follow up: the subjects in Telbivudine group start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continue to one month after delivery.And their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
Telbivudine
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
Control
The pregnant subjects in Control group are intervented with no drugs, but their newborns are given HBIG 200IU by injection immediately after born and at day 15. They are also injected with genetically engineered HB vaccine 20ug respectively at age of 0, 1 and 6 months.
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.
Interventions
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Telbivudine
Subjects start dosing Telbivudine orally at 20-32 gestational weeks, with 600 mg daily, continued to one month after delivery.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* positive serum HBsAg;
* HBV DNA≥1.0x106 copies/ml;
Exclusion Criteria
* with clinical sign of threatened miscarriage or related treatment in early pregnancy;
* positive serum HAV, HCV, HDV and HEV tests;
* fetus deformity by 3-D ultrasound examination;
* on other dugs, such as immune modulators, cytotoxic drugs or steroids;
* husbands are infected with HBV.
20 Years
40 Years
FEMALE
No
Sponsors
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Southeast University, China
OTHER
Responsible Party
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the Second Hospital of Nanjing, China
Principal Investigators
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Wei Zhao, P.H.D
Role: STUDY_CHAIR
the Second Affiliated Hospital of Southeast University
References
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Han GR, Jiang HX, Wang CM, Ding Y, Wang GJ, Yue X, Zhou L, Zhao W. Long-term safety and efficacy of telbivudine in infants born to mothers treated during the second or third trimesters of pregnancy. J Viral Hepat. 2017 Jun;24(6):514-521. doi: 10.1111/jvh.12670. Epub 2017 Feb 14.
Other Identifiers
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H200804
Identifier Type: -
Identifier Source: org_study_id
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