Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Hua Zhang

Status and phase: Completed; Phase 4

Conditions: Viremia; Hepatitis B Infection; Chronic Infection

Treatments: Drug: Lamivudine; Drug: Telbivudine

Study type: Interventional

Funder types: Other

Identifiers

NCT01788371

2011.6

Details and patient eligibility

About

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Full description

Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Enrollment: 700 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA>log10 copies/ml

Exclusion criteria

co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 3 patient groups

No antiviral arm

No Intervention group

Description:

provide standard of care to mothers and standard immunoprophylaxis to their infants

Lamivudine

Experimental group

Description:

lamivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Treatment:

Drug: Lamivudine

Telbivudine

Experimental group

Description:

Telbivudine treatment from 28 weeks of pregancy to week 4 of postpartum for mothers and standrd immunoprophylaxis to their infants

Treatment:

Drug: Telbivudine