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

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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
Sponsor:
Information provided by (Responsible Party):
Wei Yi, Beijing Ditan Hospital

Brief 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.


Condition or disease Intervention/treatment
the Safety of Anti-viral Drugs Used in Late Pregnancy Drug: Lamivudine Drug: Telbivudine Drug: Tenofovir

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis B

Group/Cohort Intervention/treatment
group A
The one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy
Drug: Lamivudine
mothers use Lamivudine in late pregnancy
Other Names:
  • 3-TC
  • CAS: 134678-17-4

group B
The one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy
Drug: Telbivudine
mothers use Telbivudine in late pregnancy
Other Name: CAS: 3424-98-4

group C
The one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy
Drug: Tenofovir
mothers use Tenofovir in late pregnancy
Other Names:
  • Tenofovir Disoprox
  • CAS: 147127-20-6

group D
The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The one year old children born in BeiJing DiTan Hospital and whose mothers had taken Lamivudine, Telbivudine or Tenofovir and untreated in late pregnancy with HBV DNA level over 6.0 log10 IU/ml
Criteria

Inclusion Criteria:

  • The one year old children whose mothers had taken Lamivudine,Telbivudine or Tenofovir in late pregnancy(28-30 weeks of gestation);
  • The one year old children whose mothers untreated in late pregnancy;
  • Children had completed standard hepatitis B vaccine and hepatitis B immune globulin combined active and passive prophylaxis;
  • HBV DNA level of the children's mothers were over 6.0 log10 IU/ml before 28 weeks of gestation.

Exclusion Criteria:

  • Children whose mothers over 35 years old at delivery;
  • The couple having family hereditary disease or abnormal malformation has been found at fetal screening before 28 weeks gestation;
  • History of amniocentesis during pregnancy;
  • Co-infection with either hepatitis C virus, hepatitis D virus, human immunodeficiency virus, syphilis, toxoplasmosis, rubella or cytomegalovirus.
  • Complications of pregnancy-induced hypertension, premature rupture of membranes, preterm birth, placenta previa or placental abruption; asphyxia at birth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301650


Sponsors and Collaborators
Beijing Ditan Hospital
Investigators
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Principal Investigator: Wei Yi Beijing Ditan Hospital

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Responsible Party: Wei Yi, Chief physician, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT02301650     History of Changes
Other Study ID Numbers: Z141107002514131
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Wei Yi, Beijing Ditan Hospital:
Hepatitis B virus
pregnancy
nucleoside (acid) analogs
children
safety

Additional relevant MeSH terms:
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Tenofovir
Lamivudine
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents