Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
NCT ID: NCT01337791
Last Updated: 2011-04-19
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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COMPLETED
PHASE4
88 participants
INTERVENTIONAL
2008-08-31
2009-12-31
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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control
Telbivudine treatment
Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment
telbivudine
No interventions assigned to this group
Interventions
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Telbivudine treatment
Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment
Eligibility Criteria
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Inclusion Criteria
* gestational age between 12-30 weeks
* serum HBsAg and HBeAg positivity
* HBV DNA levels \>6log10 copies/mL
* ALT \>1x ULN (40 IU/mL) and \< 10x ULN.
Exclusion Criteria
* evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity
* concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
* clinical signs of threatened miscarriage in early pregnancy
* evidence of fetal deformity by 3-dimensional ultrasound examination
* the biological father of the child had CHB
20 Years
40 Years
FEMALE
No
Sponsors
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Southeast University, China
OTHER
Responsible Party
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The Second Affiliated Hospital of the Southeast University
Locations
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Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, China
Countries
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References
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Pan CQ, Han GR, Jiang HX, Zhao W, Cao MK, Wang CM, Yue X, Wang GJ. Telbivudine prevents vertical transmission from HBeAg-positive women with chronic hepatitis B. Clin Gastroenterol Hepatol. 2012 May;10(5):520-6. doi: 10.1016/j.cgh.2012.01.019. Epub 2012 Feb 14.
Other Identifiers
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H200804IRB
Identifier Type: -
Identifier Source: org_study_id
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