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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast University, China
• Treatments: Telbivudine

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