Immune Globulin, Prophylaxis, Telbuvidine, VaccineNCT02253485
Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load
An observational study of Immune Globulin, Prophylaxis, Telbuvidine, Vaccine, run by Beijing Ditan Hospital.
Trial summary
Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. Read more about this study
- Who is it for?
- Ages Up to 7 months
- Conditions the study is for
- Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
- What is being tested?
- telbivudine
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2015
- 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 Up to 7 months
- All sexes
- No healthy volunteers
- Child
Study population: this study would enroll 600 HBsAg positive mothers, including 240 cases with high serum HBV DNA load during pregnancy, 120 cases treated with antiviral therapy for hepatitis B, 120 cases with HBV DNA negative during pregnancy, 120 cases with high serum HBV DNA but receive antiviral therapy in late of pregnancy, and all of their infants.
Who may be able to join
- infants born to HBsAg positive mother HBsAg positive mother
Who cannot join
- mothers coinfected HIV or HCV
About this study
Official title: Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load
Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.
Read the detailed description
This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.
- Being tested
- telbivudine
- Keywords
- Mother-to-child transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telbivudineDrug
in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.
in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV.
| Study group | Role | What they receive |
|---|---|---|
| telbivudine treated entire pregnancy | mothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV. Receives: Drug: telbivudine | |
| telbivudine treated in late pregnancy | mothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV. Receives: Drug: telbivudine | |
| HBV DNA positive control | infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV. | |
| HBV DNA negative control | infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
mother-to-child transmission of HBV
HBV infenction in infants at 7 months after birth
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startAug 2012
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Globulin, Prophylaxis, Telbuvidine, VaccineStudies 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
- 600 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
- NCT02253485
- Sponsor's protocol ID
- D121100003912001
- Status last verified
- Aug 2012
- First submitted
- 29 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yi W, Li MH, Xie Y, Wu J, Hu YH, Zhang D, Zhang Y, Cao WH. Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother-to-child transmission of hepatitis B virus. J Viral Hepat. 2017 Nov;24 Suppl 1:49-56. doi: 10.1111/jvh.12788.
PubMed 29082650
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load
- ClinicalTrials.gov ID
- NCT02253485
- Acronym / sponsor ID
- D121100003912001
- Keywords
- Mother-to-child transmission
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Beijing Ditan HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Oct 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 most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.
Detailed description
This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| telbivudine treated entire pregnancy | – | Drug: telbivudinemothers in this group were treated with antiviral therapy during entire pregnancy for hepatitis, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV. |
| telbivudine treated in late pregnancy | – | Drug: telbivudinemothers with high serum HBV DNA load were treated with antiviral therapy in late pregnancy, and their infants receive standard immunoprophylaxis for preventing MTCT of HBV. |
| HBV DNA positive control | – | –infants in this group born to mother with high serum HBV DNA load and receive standard immunoprophylaxis or additional HBIG injection at 1 month after birth for preventing MTCT of HBV. |
| HBV DNA negative control | – | –infants in this group born to a HBsAg positive and serum HBV DNA negative mothers and receive standard immunoprophylaxis for preventing MTCT of HBV |
Who may qualify
- Ages
- Up to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- this study would enroll 600 HBsAg positive mothers, including 240 cases with high serum HBV DNA load during pregnancy, 120 cases treated with antiviral therapy for hepatitis B, 120 cases with HBV DNA negative during pregnancy, 120 cases with high serum HBV DNA but receive antiviral therapy in late of pregnancy, and all of their infants.
Key inclusion criteria (1 listed)
- infants born to HBsAg positive mother HBsAg positive mother
Key exclusion criteria (1 listed)
- mothers coinfected HIV or HCV
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 |
|---|---|---|
| telbivudinein telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B. in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV. | Drug | telbivudine treated entire pregnancy, telbivudine treated in late pregnancy |
Primary outcome
mother-to-child transmission of HBV
Time frame: 7 months
HBV infenction in infants at 7 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Derived from this study: PubMed 29082650Yi W, Li MH, Xie Y, Wu J, Hu YH, Zhang D, Zhang Y, Cao WH. Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother-to-child transmission of hepatitis B virus. J Viral Hepat. 2017 Nov;24 Suppl 1:49-56. doi: 10.1111/jvh.12788.
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 Immune Globulin, Prophylaxis, Telbuvidine, Vaccine, 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 1 inclusion and 1 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 1 Oct 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?
mother-to-child transmission of HBV (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02253485, which also lists 1 linked publication.
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 1 Oct 2014.