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

Primary Purpose

Chronic Hepatitis B, Pregnancy Complications, High Viral Load

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Telbivudine treatment
Sponsored by
Southeast University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

No Intervention

Arm Label

control

telbivudine

Arm Description

Outcomes

Primary Outcome Measures

The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety

Secondary Outcome Measures

Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg

Full Information

First Posted
April 15, 2011
Last Updated
April 18, 2011
Sponsor
Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01337791
Brief Title
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southeast University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B, Pregnancy Complications, High Viral Load, Elevated Alanine Aminotransferase Levels
Keywords
chronic hepatitis B, hepatitis B virus, perinatal transmission, Telbivudine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Title
telbivudine
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Telbivudine treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg
Time Frame
From late pregnancy to 28 weeks of postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University
City
Nan Jing
State/Province
Jiang Su
ZIP/Postal Code
210003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22343511
Citation
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.
Results Reference
derived

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

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