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

Phase 4

Completed

• Conditions: Elevated Alanine Aminotransferase Levels; Chronic Hepatitis B; Pregnancy Complications; High Viral Load
• Interventions: Drug: Telbivudine treatment

• Registration Number: NCT01337791
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Last Update Submitted: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Telbivudine treatment	-

Primary Outcome Measures

Name	Time	Method
The efficacy of Telbivudine treatment (DNA reduction, ALT normalization, and infants' immunoprophylaxis failure) and safety	From late pregnancy to 28 weeks of postpartum

Secondary Outcome Measures

Name	Time	Method
Changes in maternal HBeAg titers and lost/seroconversion of HBeAg or HBsAg	From late pregnancy to 28 weeks of postpartum

Trial Locations

Locations (1)

Department of Gynecology and Obstetrics, The Second Affiliated Hospital of the Southeast University; 🇨🇳 Nan Jing, Jiang Su, China