NCT01337791|CompletedPhase 4DMC
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Sponsor study identifier
interventional
88
1 country
1
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic hepatitis B patients with few adverse effects, but its use during pregnancy has not been explored. In this open-label, prospective study from the second trimester to post-partum week 28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated alanine aminotransferase levels.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2009
Actual (reported)December 2009
Actual (reported)April 15, 2011
Actual (reported)April 19, 2011
Actual (reported)The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety
From late pregnancy to 28 weeks of postpartum
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg
From late pregnancy to 28 weeks of postpartum
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
Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, 210003, China
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.
88 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2011
First Posted
April 19, 2011
Study Start
August 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2009
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
April 19, 2011
Record last verified: 2011-04
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Source: ClinicalTrials.gov.
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