Clinical trial NCT02510963: Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy
Official title: An Open-label, Randomized, Controlled Clinical Trial to Determine the Optimal Time for Tenofovir of Anti-HBV Treatment During the Pregnancy Among Chronic HBV-infected Pregnant Women With Normal Liver Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis B, Chronic
Keywords: Vertical infection transmission
Tenofovir
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: HBV DNA load in serum
timeFrame: 40 weeks, from randomization to delivery
Secondary outcomes:
measure: Intrauterine HBV infection rate of infants
timeFrame: 12 months, from delivery to one-year birth date
measure: Change in HBV DNA load
timeFrame: 40 weeks, from randomization to delivery
measure: Change in hepatitis B e antigen (HBeAg) titer
timeFrame: 40 weeks, from randomization to delivery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Tianyan Chen, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References: