This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Southeast University, China Identifier:
First received: April 15, 2011
Last updated: April 18, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Chronic Hepatitis B Pregnancy Complications High Viral Load Elevated Alanine Aminotransferase Levels Drug: Telbivudine treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Southeast University, China:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg [ Time Frame: From late pregnancy to 28 weeks of postpartum ]

Enrollment: 88
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control 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: telbivudine


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01337791

China, Jiang Su
Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
Nan Jing, Jiang Su, China, 210003
Sponsors and Collaborators
Southeast University, China
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Guo-Rong Han, The Second Affiliated Hospital of the Southeast University Identifier: NCT01337791     History of Changes
Other Study ID Numbers: H200804IRB
Study First Received: April 15, 2011
Last Updated: April 18, 2011

Keywords provided by Southeast University, China:
chronic hepatitis B
hepatitis B virus
perinatal transmission

Additional relevant MeSH terms:
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Pregnancy Complications
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017