the Safety of Anti-viral Drugs Used in Late PregnancyNCT02301650
The Effect of Anti-viral Drugs Used in Late Pregnancy on Long-term Development of Children
An observational study of the Safety of Anti-viral Drugs Used in Late Pregnancy, run by Beijing Ditan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- the Safety of Anti-viral Drugs Used in Late Pregnancy
- What is being tested?
- Lamivudine, Telbivudine and Tenofovir
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Being tested
- Lamivudine, Telbivudine, Tenofovir
- Keywords
- Hepatitis B virus, pregnancy, nucleoside (acid) analogs, children, safety
- Medical subject headings
- Hepatitis B, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamivudineDrug
Also called 3-TC, CAS: 134678-17-4
mothers use Lamivudine in late pregnancy
TelbivudineDrug
Also called CAS: 3424-98-4
mothers use Telbivudine in late pregnancy
TenofovirDrug
Also called Tenofovir Disoprox, CAS: 147127-20-6
mothers use Tenofovir in late pregnancy
| Study group | Role | What they receive |
|---|---|---|
| group A | The one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy Receives: Drug: Lamivudine | |
| group B | The one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy Receives: Drug: Telbivudine | |
| group C | The one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy Receives: Drug: Tenofovir | |
| group D | The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of abnormal development
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Safety of Anti-viral Drugs Used in Late PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Ditan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Yi, Beijing Ditan Hospital
- Investigators
- Wei Yi, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301650
- Sponsor's protocol ID
- Z141107002514131
- Status last verified
- Nov 2014
- First submitted
- 12 Nov 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02301650
- Acronym / sponsor ID
- Z141107002514131
- Keywords
- Hepatitis B virus, pregnancy, nucleoside (acid) analogs, children, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | – | Drug: LamivudineThe one year old children born in Beijing Ditan hospital and whose mothers had taken Lamivudine in late pregnancy |
| group B | – | Drug: TelbivudineThe one year old children born in Beijing Ditan hospital and whose mothers had taken Telbivudine in late pregnancy |
| group C | – | Drug: TenofovirThe one year old children born in Beijing Ditan hospital and whose mothers had taken Tenofovir in late pregnancy |
| group D | – | –The one year old children born in Beijing Ditan hospital and whose mothers untreated in late pregnancy |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LamivudineAlso: 3-TC, CAS: 134678-17-4mothers use Lamivudine in late pregnancy | Drug | group A |
| TelbivudineAlso: CAS: 3424-98-4mothers use Telbivudine in late pregnancy | Drug | group B |
| TenofovirAlso: Tenofovir Disoprox, CAS: 147127-20-6mothers use Tenofovir in late pregnancy | Drug | group C |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Yi principal investigator
Beijing Ditan Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of the Safety of Anti-viral Drugs Used in Late Pregnancy, run by Beijing Ditan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of abnormal development (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.