Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels

This study has been completed.

Sponsor:

Information provided by:

Southeast University, China

ClinicalTrials.gov Identifier:

NCT01337791

First received: April 15, 2011

Last updated: April 18, 2011

Last verified: April 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	April 15, 2011
Last Updated Date	April 18, 2011
Start Date ^ICMJE	August 2008
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 18, 2011)	The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety [ Time Frame: From late pregnancy to 28 weeks of postpartum ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01337791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 18, 2011)	Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg [ Time Frame: From late pregnancy to 28 weeks of postpartum ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Hepatitis B Pregnancy Complications High Viral Load Elevated Alanine Aminotransferase Levels
Intervention ^ICMJE	Drug: 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
Study Arm (s)	No Intervention: control Intervention: Drug: Telbivudine treatment No Intervention: telbivudine
Publications *	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. Epub 2012 Feb 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	88
Completion Date	December 2009
Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: age between 20-40 years 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: co-infection with hepatitis A, C, D, E or HIV 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
Gender	Female
Ages	20 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01337791
Other Study ID Numbers ^ICMJE	H200804IRB
Has Data Monitoring Committee	Yes
Responsible Party	Guo-Rong Han, The Second Affiliated Hospital of the Southeast University
Study Sponsor ^ICMJE	Southeast University, China
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Southeast University, China
Verification Date	April 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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