Back to resultsMaternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Primary Purpose
Hepatitis B Virus Infection
Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tenofovir Alafenamide
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B Virus Infection
Eligibility Criteria
Inclusion criteria:
- Women aged 20-45 years in 28 to 32 weeks of pregnancy
- Positive HBsAg and HBeAg
- Serum viral load above 6 log10 IU/mL
Exclusion criteria:
- Major systemic disease of the mother or fetus
- Positive anti-HIV or anti-HCV
- Under treatment of antiviral therapy
- Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
- Pregnant woman whose amniocentesis reveals any genetic abnormality
Sites / Locations
- National Taiwan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
treatment group
control group
Arm Description
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
control group receive no drug, only follow-up
Outcomes
Primary Outcome Measures
Child HBsAg 6 mo
Serum status of HBsAg of the infants at 6 months old
Secondary Outcome Measures
Child HBsAg 12 mo
Serum status of HBsAg of the infants at 12 months old
Maternal ALT elevation
Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery
Maternal HBeAg-seroconverion
HBeAg-seroconversion rate within 12 months after delivery
Maternal renal
Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery
Materna bone marker
Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery
Children's growth
Children's growth: height (cm) in Z score at 6 and 12 months after birth
Children's growth
Children's growth: weight (kg) in Z score at 6 and 12 months after birth
Full Information
NCT ID
NCT03695029
First Posted
September 20, 2018
Last Updated
November 25, 2020
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03695029
Brief Title
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Official Title
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 29, 2010 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant HBV transmission, and to access the safety of such treatment for mothers and infants.
Detailed Description
This is a multi-centered study conducted in 12-16 collaborative hospitals in Taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. The study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (TDF) 2011-2018, June, and receive tenofovir alafenamide (TAF) 2018-2021. Control group did not receive antiviral treatment. Both group receive mother and infant follow-up up to 12 months after delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
Arm Title
control group
Arm Type
No Intervention
Arm Description
control group receive no drug, only follow-up
Intervention Type
Drug
Intervention Name(s)
Tenofovir Alafenamide
Intervention Description
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
Primary Outcome Measure Information:
Title
Child HBsAg 6 mo
Description
Serum status of HBsAg of the infants at 6 months old
Time Frame
6 months after delivery
Secondary Outcome Measure Information:
Title
Child HBsAg 12 mo
Description
Serum status of HBsAg of the infants at 12 months old
Time Frame
12 months after delivery
Title
Maternal ALT elevation
Description
Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery
Time Frame
6 months after delivery
Title
Maternal HBeAg-seroconverion
Description
HBeAg-seroconversion rate within 12 months after delivery
Time Frame
12 months after delivery
Title
Maternal renal
Description
Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery
Time Frame
6 and 12 months post delivery
Title
Materna bone marker
Description
Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery
Time Frame
6 and 12 months post delivery
Title
Children's growth
Description
Children's growth: height (cm) in Z score at 6 and 12 months after birth
Time Frame
6 and 12 months after birth
Title
Children's growth
Description
Children's growth: weight (kg) in Z score at 6 and 12 months after birth
Time Frame
6 and 12 months after birth
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Women aged 20-45 years in 28 to 32 weeks of pregnancy
Positive HBsAg and HBeAg
Serum viral load above 6 log10 IU/mL
Exclusion criteria:
Major systemic disease of the mother or fetus
Positive anti-HIV or anti-HCV
Under treatment of antiviral therapy
Pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus
Pregnant woman whose amniocentesis reveals any genetic abnormality
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mei-Hwei Chang
Phone
+886-2-23123456
Ext
71701
Email
changmh@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivy Chiou
Phone
+886-2-23123456
Ext
71737
Email
ivyntuh@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
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