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

April 15, 2011
April 18, 2011
August 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01337791 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis B
  • Pregnancy Complications
  • High Viral Load
  • Elevated Alanine Aminotransferase Levels
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
  • No Intervention: control
    Intervention: Drug: Telbivudine treatment
  • No Intervention: telbivudine
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
20 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01337791
H200804IRB
Yes
Guo-Rong Han, The Second Affiliated Hospital of the Southeast University
Southeast University, China
Not Provided
Not Provided
Southeast University, China
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP