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Trial record 94 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified August 2016 by First Affiliated Hospital Xi'an Jiaotong University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02510963
First Posted: July 29, 2015
Last Update Posted: August 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University
  Purpose
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.

Condition Intervention
Hepatitis B, Chronic Drug: Tenofovir Disoproxil Fumarate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by First Affiliated Hospital Xi'an Jiaotong University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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

  • 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


Estimated Enrollment: 300
Study Start Date: November 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Tenofovir Disoproxil Fumarate
Use Tenofovir at 24week of gestation
Other Name: 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
Drug: Tenofovir Disoproxil Fumarate
Use Tenofovir at 28week of gestation
Other Name: 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
Drug: Tenofovir Disoproxil Fumarate
Use Tenofovir at 32week of gestation
Other Name: Tenofovir

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02510963


Contacts
Contact: Jinfeng Liu, MB +86-13259927840 prettycaofurong@163.com
Contact: Jing Wang, MD,PHD +86-18092691661 kidip@163.com

Locations
China
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, China, 710061
Contact: Tianyan Chen    86-18991232530      
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Principal Investigator: Tianyan Chen, MD,PHD First Affiliated Hospital Xi'an Jiaotong University
  More Information

Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT02510963     History of Changes
Other Study ID Numbers: XJTU1AHCR2014-013
First Submitted: July 22, 2015
First Posted: July 29, 2015
Last Update Posted: August 10, 2016
Last Verified: August 2016

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Vertical infection transmission
Tenofovir

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents