chronic HBV infection
Conditions
Interventions
TAF group:receive TAF (25 mg oral daily) treatment
control group:receive no treatment
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Serum HBsAg, HBeAg positive; (2) HBV DNA >=2x10^6 IU / ml; (3) Guaranteed perinatal examination and childbirth in the subject research unit; (4) Aged 20 to 35 years; (5) Good compliance and corresponding interventions; (6) Understand research and sign informed consent.
Exclusion criteria
Exclusion criteria: co-infection with (HIV)-1, or hepatitis A, C, D, E or 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; creatinine clearance5 times upper limit of the normal; total bilirubin >34.2umol/L; albumin <25g/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; and fetuss biological father had CHB infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mother to child transmission rate;safety of TAF therapy in mothers andinfants; | — |
Secondary
| Measure | Time frame |
|---|---|
| the reduction of maternal HBV DNA levels at delivery;the loss/seroconversion of HBsAg or/and HBeAg;ALT normalization rate; | — |
Countries
China
Contacts
Public ContactDuan Zhongping
Beijing You'an Hospital, Capital Medical University
Outcome results
None listed