Status:
UNKNOWN
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
Lead Sponsor:
New Discovery LLC
Conditions:
Hepatitis B Infection
Congenital Malformation
Eligibility:
FEMALE
20-35 years
Phase:
PHASE4
Brief Summary
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus ...
Detailed Description
This is a multicenter, prospective, randomized, open-label and parallel two arm study starting from week 14-16 of pregnancy to post-partum week 28. The enrollment from approximately 7 centers will be ...
Eligibility Criteria
Inclusion
- HBeAg-positive CHB mothers
- Age of 20-35 years old
- Serum HBV DNA levels \> 200,000 IU/mL
- Gestational age between 12-14 weeks.
- Both mother and father of the child have the ability to understand and are willing to consent to the study.
Exclusion
- Co-infection with (HIV)-1, or hepatitis A, C, D, E or sexual transmitted diseases (STD)
- History of abortion or congenital malformation in a prior pregnancy
- Treatment experience (except when antivirals were used for MTCT prevention in a previous pregnancy and discontinued \>6 months prior to the current pregnancy)
- History of renal dysfunction; evidence of liver cancer or decompensation
- Estimated creatinine clearance (CLCr) \<100 mL/min (using the Cockcroft-Gault method based on serum creatinine and ideal body weight)
- Hypo-phosphoremia; hemoglobin \<8 g/dL; neutrophil count \<1,000//μL; alanine aminotransferase \>5 times upper limit of the normal; total bilirubin \>2 mg/dL; albumin \<25gm/L;
- Clinical signs of threatened miscarriage
- Ultrasonographic evidence of fetal deformity
- Concurrent treatment with nephrotoxic drugs, steroids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators;
- Recipient of solid organ or bone marrow transplant
- Significant renal, cardiovascular, pulmonary, neurological disease or other health conditions in the opinion of the investigator
- Fetus's biological father had CHB infection
Key Trial Info
Start Date :
June 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03476083
Start Date
June 10 2018
End Date
May 1 2024
Last Update
December 12 2019
Active Locations (7)
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1
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
2
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038
3
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, China, 510623
4
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050021