Intrauterine infection 0f hepatitis B virus
Conditions
Interventions
Control Group:no
telbivudine group:telbivudine 600mg/day, oral
Sponsors
The Nangjing Second Hospital Affiliated Southeast Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women from 24 to 32 weeks of gestation; 2. HBsAg and HBeAg of blood serum have been positive for more than 6 months; 3. HBV-DNA quantitation of blood plasma > 1,000,000 copy/ml; 4. Alanine aminotransferase is normal or abnormal in 2 to10 times higher than top limit of normal value; 5. Compensatory liver disease that PT prolong not more than 3 minutes, TBIL not more than 2 times of normal value; albumin and creatinine are normal; 6. To be willing to assign informed consent and abide by treatment scheme as well as follow-up plan; 7. HBsAg, HBeAg, HBV DNA of her husband are all negative.
Exclusion criteria
Exclusion criteria: 1. B-type sonography find fetal abnormal or has history of threatened abortion; 2. One of antibodies of heptitis A, C, D virus and human immunodeficiency virus is positive; 3. Severe malnutrition, kidney disease, diabetes etc diseases; 4. Amphibiotic apparent cardiovascular disease or electrocardiogram shows obvious abnormality; 5. Has ever received any antiviral therapy with interferon, immunomodulator, nucleoside analog, etc al in 6 months before the study; 6. The patients who are thought to be unfit for being selected to the study or have the other factors that may have influence on participation of patients or accomplishment of the study; 7. With pathological changes of muscles or high creatine kinase; 8. With any complication in pregnancy which may lead to abnormal Hepatic function such as eclamptism or eclampsismy or intrahepatic cholestasis of pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA;HBV-m, HBsAb, HBeA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver function: ALT, AST, TB, ALB;WBC and Plt concentration;CK;BUN and Cr concentration; | — |
Countries
China
Contacts
Public ContactMinMin YU
Outcome results
None listed