Status:
COMPLETED
The Safety of Anti-viral Therapy in Preventing HBV MTCT in Pregnant Women After Discontinuation
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Hepatitis B, Chronic
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Mother-to-child transmission (MTCT) is the most common mode of perpetuating chronic hepatitis B virus (HBV) infection in endemic countries. Many studies have demonstrated antepartum anti-viral therapy...
Detailed Description
Between June 2015 and December 2017, 111 mothers were enrolled during their visit to the Department of Gynecology and Obstetrics or the Department of Infectious Diseases of the Third Affiliated Hospit...
Eligibility Criteria
Inclusion
- Gestational age between 24 and 28 weeks
- Detectable serum HBsAg at the Screening visit and at least 6 months prior
- Serum HBV DNA level \>1,000,000 IU/mL at Screening visit
- Alanine aminotransferase (ALT) below the upper limit of normal (ULN; 40 IU/mL)
Exclusion
- Patient is co-infected with hepatitis A virus, hepatitis C virus, hepatitis delta virus, hepatitis E virus or HIV.
- Patient has a history of antiviral treatment or concurrent treatment with immunomodulators, cytotoxic drugs, or steroids.
- Patient has clinical signs of threatened miscarriage in early pregnancy.
- Patient has evidence of hepatocellular carcinoma or cirrhosis.
- Patient has evidence of fetal deformity by 3-dimensional ultrasound examination.
- Patient has a husband infected with HBV.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT03468907
Start Date
June 1 2015
End Date
December 31 2017
Last Update
August 29 2018
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