A Study of the Interruption on the Mother-to-child Transmission of Hepatitis B Virus （HBV MTCT）in Newborns at High Risk
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|ClinicalTrials.gov Identifier: NCT02901418|
Recruitment Status : Unknown
Verified September 2016 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2016
Last Update Posted : September 20, 2016
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis B||Biological: 200 IU HBIG|
|Study Type :||Observational|
|Estimated Enrollment :||406 participants|
|Observational Model:||Case Control|
|Official Title:||According to the Venous Blood HBsAg State of Neonatus at Birth, Discussing the Efficiency of Personalized Blocking Method of HBV Maternal-neonatal Transmission in High-risk Newborns|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
In this group,these children born in about two hours, we injected HBIG 200 iu and 10 micrograms of hepatitis b vaccine in their left and right thigh respectively, then injected 10 micrograms again in 1 and 6 months.
In this group,about 2 hours after birth, respectively injecting HBIG 200 IU and 10 micrograms of hepatitis b vaccine in the right and left thigh, and in 1 and 6 months again taking 10 micrograms of standard solution, in addition, offering the additional injection of 200 IU HBIG within 24 hours.
Biological: 200 IU HBIG
additional 200 IU HBIG within 24 hours was used for the experimental group of newborns
Other Name: hepatitis B immune globulin
- blocking rate of vertical transmission of hepatitis B [ Time Frame: seven months ]At the birth of 7 months, the venous blood serum HBsAg positive was defined as the failure of the interruption of HBV mother-to-child transmission.
- anti HBs level at the age of one month and seven months [ Time Frame: one month and seven months ]Observing the level of anti HBs, then discussing the efficiency of personalized blocking method of HBV maternal-neonatal transmission
Biospecimen Retention: Samples With DNA
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): NCT02901418
|Contact: Yao Xie, MDfirstname.lastname@example.org|
|Beijing Ditan hospital,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100015|
|Contact: Yao Xie, doctor 8613501093293 email@example.com|
|Principal Investigator: Yao Xie, doctor|