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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 12, 2014
First Posted Date November 26, 2014
Last Update Posted Date November 26, 2014
Study Start Date October 2014
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2014)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition the Safety of Anti-viral Drugs Used in Late Pregnancy
Intervention
  • Drug: Lamivudine
    mothers use Lamivudine in late pregnancy
    Other Names:
    • 3-TC
    • CAS: 134678-17-4
  • Drug: Telbivudine
    mothers use Telbivudine in late pregnancy
    Other Name: CAS: 3424-98-4
  • Drug: Tenofovir
    mothers use Tenofovir in late pregnancy
    Other Names:
    • Tenofovir Disoprox
    • CAS: 147127-20-6
Study Groups/Cohorts
  • group A
    The one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy
    Intervention: Drug: Lamivudine
  • group B
    The one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy
    Intervention: Drug: Telbivudine
  • group C
    The one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy
    Intervention: Drug: Tenofovir
  • group D
    The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 22, 2014)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Year to 3 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02301650
Other Study ID Numbers Z141107002514131
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wei Yi, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Wei Yi Beijing Ditan Hospital
PRS Account Beijing Ditan Hospital
Verification Date November 2014