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Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

H

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

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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