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

Xi'an Jiaotong University

Status: Unknown

Conditions: Hepatitis B, Chronic

Treatments: Drug: Tenofovir Disoproxil Fumarate

Study type: Interventional

Funder types: Other

Identifiers

NCT02510963

XJTU1AHCR2014-013

Details and patient eligibility

About

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.

Full description

Tenofovir Disoproxil Fumarate is a American Food and Drug Administration (FDA) pregnancy class B drug. To determine the optimal time for the tenofovir treatment during the pregnancy among women with chronic HBV infection and high HBV DNA load. Pregnant women with high HBV DNA load and normal liver function at second trimester will be randomized into three treatment groups at the 20th week of gestation and treated with tenofovir from 24 weeks, 28 weeks and 32 weeks to 1 month postpartum, respectively. The blood will be drawn at 24 weeks, 28 weeks, 32 weeks, 36 weeks and the delivery, respectively and the HBV DNA load and liver functions will be tested. The status of HBV infection for infants will be observed at 1st month, 7th month and 12th month after the babies were delivered. The HBV DNA load at 40th gestational week of mothers, the intrauterine HBV infection rate of infants and safety outcomes will be compared across the three groups.

Enrollment: 300 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Tenofovir 24 week

Experimental group

Description:

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 24 weeks of gestation to 1 month postpartum

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate

Tenofovir 28 week

Experimental group

Description:

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 28 weeks of gestation to 1 month postpartum

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate

Tenofovir 32 week

Active Comparator group

Description:

Pregnant women with high HBV DNA load in serum and normal liver function were treated with Tenofovir Disoproxil Fumarate 300 mg/day from 32 weeks of gestation to 1 month postpartum

Treatment:

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate

Drug: Tenofovir Disoproxil Fumarate