Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the optimal time for the Tenofovir treatment of anti-Hepatitis B Virus (HBV) during the pregnancy among women with chronic HBV infection and high HBV DNA load. This is a randomized, open-label, three-arms, parallel-controlled clinical trial. Pregnant women with high HBV load and normal liver function will be treated with tenofovir during the middle or late stage of pregnancy, started from 24th gestational week, 28th gestational week and 32th gestational week through 1 month postpartum, respectively. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants will be compared across the three groups.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Tenofovir

Criteria

Inclusion Criteria:

• Women between 20 and 40 years old

• Have had HBsAg positive in serum greater than 6 months

• HBV DNA load>10**6 IU/ml

• Gestation week<24 weeks

• Normal liver function

• Able to comprehend and willing to sign the informed consent form

Exclusion Criteria:

• Combined with following infections: hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV) and human immunodeficiency virus (HIV)

• Got antiviral treatments before 24 weeks of Gestation

• Got immunosuppressor treatment and/or steroids

• Got diagnosis of cirrhosis,hepatocellular carcinoma or severe hepatitis B

• Got serious obstetric complications

• Got evidence of fetal deformity diagnosed by four-dimensional color Doppler ultrasound examination

• Biological father of infant had HBV infection