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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01337791
Recruitment Status : Completed
First Posted : April 19, 2011
Last Update Posted : April 19, 2011
Information provided by:
Southeast University, China

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg [ Time Frame: From late pregnancy to 28 weeks of postpartum ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: April 19, 2011    Key Record Dates
Last Update Posted: April 19, 2011
Last Verified: April 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