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The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children

NCT02301650 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2014-11-26

No results posted yet for this study

Summary

Mother to child transmission(MTCT) is the main route of hepatitis B virus(HBV) transmission.High HBV DNA level of pregnant women is the main risk factor of MTCT. Many literatures demonstrate that using nucleoside (acid) analogs in late pregnancy can significantly reduce HBV DNA level and effectively blocking MTCT. Therefore, treatment guidelines of hepatitis B in Europe and the Asia Pacific region clearly pointed out: Nucleoside (acid) analogs can be used in pregnant women after 28 weeks of gestation for blocking MTCT in mothers with high HBV DNA level. At present, the drugs used in late pregnancy including lamivudine (LAM) ,telbivudine(LdT) and tenofovir(TDF).

The safety of nucleoside (acid) analogues used in late pregnancy on children is not clear.In most of the related researches,the observation termination was 7-12 months after birth, and most were concentrated on the blocking effect of MTCT.The long-term impact of Nucleoside (acid) analogues on children's development has not been reported in the literatures. The aim of this study is to make clear of the effect of nucleoside (acid) analogues used in late pregnancy on long-term impact of children's development.

The one year old children born in Beijing Ditan hospital and whose mothers had taken LAM,LdT or TDF during late pregnancy will be enrolled as study group, and eligible children whose mothers untreated will be enrolled as control group. The children's height, weight, nutritional status, developmental quotient and immune response to hepatitis B vaccine etc will be evaluated at baseline and at 3 years old. By comparing the children's development in different groups as well as in self-control of different ages, we will discuss the effect of Nucleoside (acid) analogues on children's long-term development.

Conditions

  • the Safety of Anti-viral Drugs Used in Late Pregnancy

Interventions

DRUG

Lamivudine

mothers use Lamivudine in late pregnancy

DRUG

Telbivudine

mothers use Telbivudine in late pregnancy

DRUG

Tenofovir

mothers use Tenofovir in late pregnancy

Sponsors & Collaborators

  • Beijing Ditan Hospital

    lead OTHER

Principal Investigators

  • Wei Yi · Beijing Ditan Hospital

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-10-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301650 on ClinicalTrials.gov