The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
|ClinicalTrials.gov Identifier: NCT02301650|
Recruitment Status : Unknown
Verified November 2014 by Wei Yi, Beijing Ditan Hospital.
Recruitment status was: Enrolling by invitation
First Posted : November 26, 2014
Last Update Posted : November 26, 2014
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.
|Condition or disease||Intervention/treatment|
|the Safety of Anti-viral Drugs Used in Late Pregnancy||Drug: Lamivudine Drug: Telbivudine Drug: Tenofovir|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Observational Model:||Case Control|
|Official Title:||The Effect of Anti-viral Drugs Used in Late Pregnancy in Mothers With Hepatitis B Virus Infection on Long-term Development of Children|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||December 2017|
The one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy
mothers use Lamivudine in late pregnancy
The one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy
mothers use Telbivudine in late pregnancy
Other Name: CAS: 3424-98-4
The one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy
mothers use Tenofovir in late pregnancy
The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301650
|Principal Investigator:||Wei Yi||Beijing Ditan Hospital|