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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02510963
Other study ID # XJTU1AHCR2014-013
Secondary ID
Status Recruiting
Phase N/A
First received July 22, 2015
Last updated August 9, 2016
Start date November 2015
Est. completion date August 2017

Study information

Verified date August 2016
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Jinfeng Liu, MB
Phone +86-13259927840
Email prettycaofurong@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date August 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 40 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
Tenofovir Disoproxil Fumarate
Use Tenofovir at 28week of gestation
Tenofovir Disoproxil Fumarate
Use Tenofovir at 32week of gestation

Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBV DNA load in serum 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 40 weeks, from randomization to delivery No
Secondary Intrauterine HBV infection rate of infants Intrauterine HBV infection rate of infants at the 12th months after delivery 12 months, from delivery to one-year birth date No
Secondary Change in HBV DNA load Total change in HBV DNA load from the start of treatment to the delivery was compared across the three groups 40 weeks, from randomization to delivery No
Secondary Change in hepatitis B e antigen (HBeAg) titer Total change in HBeAg titer from the start of treatment to the delivery was compared across the three groups 40 weeks, from randomization to delivery No
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