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

Not Applicable

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Tenofovir Disoproxil Fumarate

• Registration Number: NCT02510963
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-07-22
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-29
• Study Start: 2015-11
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10
• Primary Completion: 2017-06
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir 24 week	Tenofovir Disoproxil Fumarate	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
Tenofovir 28 week	Tenofovir Disoproxil Fumarate	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
Tenofovir 32 week	Tenofovir Disoproxil Fumarate	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

Primary Outcome Measures

Name	Time	Method
HBV DNA load in serum	40 weeks, from randomization to delivery	the difference in the percentage of mothers whose HBV DNA load in serum are less than 10\*2 IU/ml at delivery among the groups

Secondary Outcome Measures

Name	Time	Method
Intrauterine HBV infection rate of infants	12 months, from delivery to one-year birth date	Intrauterine HBV infection rate of infants at the 12th months after delivery
Change in HBV DNA load	40 weeks, from randomization to delivery	Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups
Change in hepatitis B e antigen (HBeAg) titer	40 weeks, from randomization to delivery	Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, China