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

Southeast University, China88 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis B Pregnancy Complications High Viral Load Elevated Alanine Aminotransferase Levels

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

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