Chronic Hepatitis B Virus
Conditions
Interventions
Immediate withdrawal Group:Stop taking nucleotide analogues after delivery
12W withdrawal Group:Continue taking nucleotide analogues until 12 weeks after delivery
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) HBeAg-positive pregnant women in immune tolerance; 2) Aged 20 to 35 year-old; 3) HBV DNA>6 log10 copies/mL or 200000 IU/mL; 4) Before the screening,the liver function is normal during this pregnancy(the normal liver function refers to ALT=40U/L); 5) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1) Combination with HIV-1 infection or chronic hepatitis C or syphilis; 2) The imaging or clinical data indicate cirrhosis; 3) Suffered from serious kidney,cardiovascular,lung or nervous system diseases; 4) Using immunotherapeutic drugs or anti-tumor drugs; 5) Use traditional Chinese medicine or plan to use Chinese medicine; 6) Not suitable for study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with severe liver dysfunction (ALT=5×baseline or 10×UNL,or elevated ALT accompanied by hypoalbuminemia or bilirubin=1×UNL); | — |
Secondary
| Measure | Time frame |
|---|---|
| The Proportion of patients with HBeAg loss or seroconversion at 36 weeks after delivery;The proportion of patients with HBsAg disappearance or seroconversion at 36 weeks after delivery;The correlation between HBV DNA and ALT levels and severe liver dysfunction before delivery;The risk factors associated with severe liver dysfunction;The proportion of late infections in babies;The proportion of patients with adverse events; | — |
Countries
China
Contacts
Public ContactWen Xie
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed