Status:
COMPLETED
Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
Lead Sponsor:
Govind Ballabh Pant Hospital
Collaborating Sponsors:
Indian Council of Medical Research
Lady Hardinge Medical College
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
Prevention of perinatal transmission is essential to decrease the global burden of chronic HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to the newborns of HB...
Eligibility Criteria
Inclusion
- Newborn babies of mothers who were found to be HBsAg positive
Exclusion
- Babies of mothers who had any symptoms of liver disease during the pregnancy such as jaundice, pruritus, ascites, or gastrointestinal bleed;
- Babies of mothers taking anti-viral treatment during pregnancy;
- Babies of mother with pregnancy related complications; and
- Babies of mothers who refused to participate in the study.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT01412567
Start Date
October 1 2005
End Date
June 1 2010
Last Update
August 9 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Lady Hardinge Medical College
New Delhi, National Capital Territory of Delhi, India, 110001