Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01788371

Enrollment

700

Registered

2013-02-11

Start date

2009-03-31

Completion date

2013-07-31

Last updated

2013-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Infection, Hepatitis B Infection, Viremia

Brief summary

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.

Detailed 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.

Interventions

DRUGTelbivudine

About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun

DRUGLamivudine

About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

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

Design outcomes

Primary

Measure	Time frame
The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants	perinatal to 28 weeks after infant delivery
Its efficacy in the reduction of HBV vertical transmission rate	perinatal to 28 weeks after infant delivery

Secondary

Measure	Time frame
Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg	perinatal to 28 weeks of postpartum

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026