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

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jing Wang, MD,PHD
  • Phone Number: +86-18092691661
  • Email: kidip@163.com

Study Locations

      • Xi'an, China, 710061
        • Recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
          • Tianyan Chen
          • Phone Number: 86-18991232530

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tenofovir 24 week
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
Use Tenofovir at 24week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 28week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 32week of gestation
Other Names:
  • Tenofovir
Experimental: Tenofovir 28 week
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
Use Tenofovir at 24week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 28week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 32week of gestation
Other Names:
  • Tenofovir
Active Comparator: Tenofovir 32 week
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
Use Tenofovir at 24week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 28week of gestation
Other Names:
  • Tenofovir
Use Tenofovir at 32week of gestation
Other Names:
  • Tenofovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV DNA load in serum
Time Frame: 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
40 weeks, from randomization to delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrauterine HBV infection rate of infants
Time Frame: 12 months, from delivery to one-year birth date
Intrauterine HBV infection rate of infants at the 12th months after delivery
12 months, from delivery to one-year birth date
Change in HBV DNA load
Time Frame: 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
40 weeks, from randomization to delivery
Change in hepatitis B e antigen (HBeAg) titer
Time Frame: 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
40 weeks, from randomization to delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tianyan Chen, MD,PHD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

July 27, 2015

First Posted (Estimate)

July 29, 2015

Study Record Updates

Last Update Posted (Estimate)

August 10, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Clinical Trials on Tenofovir Disoproxil Fumarate

Subscribe