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Completed

NCT Number: NCT01788371

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

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.

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Key information

Conditions

Hepatitis B Infection Blood-Borne Infections Chronic Infection Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Inflammation Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Infection Sepsis Systemic Inflammatory Response Syndrome Viremia Virus Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telbivudine

Drug

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

Lamivudine

Drug

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

Primary outcomes

  1. The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants

    Time frame: perinatal to 28 weeks after infant delivery

  2. Its efficacy in the reduction of HBV vertical transmission rate

    Time frame: perinatal to 28 weeks after infant delivery

Secondary outcomes

  1. Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg

    Time frame: perinatal to 28 weeks of postpartum

Sponsors and collaborators

Lead sponsor

Hua Zhang

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
Feb 11, 2013
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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