- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02510963
Optimal Time for Tenofovir Treatment of Anti-Hepatitis B Virus (HBV) During the Pregnancy
August 9, 2016 updated by: First Affiliated Hospital Xi'an Jiaotong University
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
Status
Unknown
Conditions
Intervention / Treatment
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
- Name: Jinfeng Liu, MB
- Phone Number: +86-13259927840
- Email: prettycaofurong@163.com
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:
Use Tenofovir at 28week of gestation
Other Names:
Use Tenofovir at 32week of gestation
Other Names:
|
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:
Use Tenofovir at 28week of gestation
Other Names:
Use Tenofovir at 32week of gestation
Other Names:
|
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:
Use Tenofovir at 28week of gestation
Other Names:
Use Tenofovir at 32week of gestation
Other Names:
|
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- XJTU1AHCR2014-013
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.
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