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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01337791

Locations
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

No publications provided by Southeast University, China

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guo-Rong Han, The Second Affiliated Hospital of the Southeast University
ClinicalTrials.gov Identifier: NCT01337791     History of Changes
Other Study ID Numbers: H200804IRB
Study First Received: April 15, 2011
Last Updated: April 18, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Pregnancy Complications
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 20, 2014