NCT02301650

The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children

Status unknown Last updated 22 November 2014

What this trial tests

trial testing Lamivudine in the Safety of Anti-viral Drugs Used in Late Pregnancy in 400 participants. Status unknown.

Timeline

1 October 2014

Primary endpoint
1 October 2017

1 December 2017

Quick facts

Lead sponsor	Beijing Ditan Hospital
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 October 2014
Primary completion	1 October 2017
Estimated completion	1 December 2017

Drugs / interventions tested

• Lamivudine (LAMIVUDINE) — full drug profile →
• Telbivudine — full drug profile →
• Tenofovir — full drug profile →

Conditions studied

• the Safety of Anti-viral Drugs Used in Late Pregnancy — all drugs for the Safety of Anti-viral Drugs Used in Late Pregnancy →

Sponsor

Beijing Ditan Hospital

Who can join

Adults 1 to 3, any sex, with the Safety of Anti-viral Drugs Used in Late Pregnancy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The rate of abnormal development
  Time frame: 6 months
  The children' development will be measured by Gesell Developmental Scales, including adaptability, mobility, fine motion skills, language ability and social skills.The children will be considered normal if the score is ≥86, score between 76-85 is suspicious, and score≤75 is abnormal.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Developmental consequences of children born from mothers with telbivudine treatment during late pregnancy: A prospective study with 3-year follow-up.
   Yi W, Cao X, Zeng Z, Cao W, et al · · 2021 · cited 3× · PMID 34120564 · DOI 10.1080/21505594.2021.1936769