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

Southeast University, China

Status and phase

Completed

Phase 4

Conditions

Pregnancy Complications

Chronic Hepatitis B

Elevated Alanine Aminotransferase Levels

High Viral Load

Treatments

Drug: Telbivudine treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01337791

H200804IRB

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No 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