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Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus

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ClinicalTrials.gov Identifier: NCT03695029
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Infection Drug: Tenofovir Alafenamide Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Maternal Screening and Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus
Actual Study Start Date : December 29, 2010
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021


Arm Intervention/treatment
Experimental: treatment group
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
Drug: Tenofovir Alafenamide
Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.

No Intervention: control group
control group receive no drug, only follow-up



Primary Outcome Measures :
  1. Child HBsAg 6 mo [ Time Frame: 6 months after delivery ]
    Serum status of HBsAg of the infants at 6 months old


Secondary Outcome Measures :
  1. Child HBsAg 12 mo [ Time Frame: 12 months after delivery ]
    Serum status of HBsAg of the infants at 12 months old

  2. Maternal ALT elevation [ Time Frame: 6 months after delivery ]
    Rate of postpartum maternal ALT elevation above 2X upper limit of normal within 6 months after delivery

  3. Maternal HBeAg-seroconverion [ Time Frame: 12 months after delivery ]
    HBeAg-seroconversion rate within 12 months after delivery

  4. Maternal renal [ Time Frame: 6 and 12 months post delivery ]
    Maternal serum creatinine (mg/dL) at 6 and 12 months post delivery

  5. Materna bone marker [ Time Frame: 6 and 12 months post delivery ]
    Maternal bone alkaline phosphatase (ug/L) at 6 and 12 months post delivery

  6. Children's growth [ Time Frame: 6 and 12 months after birth ]
    Children's growth: height (cm) in Z score at 6 and 12 months after birth

  7. Children's growth [ Time Frame: 6 and 12 months after birth ]
    Children's growth: weight (kg) in Z score at 6 and 12 months after birth



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   No
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

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): NCT03695029


Contacts
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Contact: Mei-Hwei Chang +886-2-23123456 ext 71701 changmh@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ivy Chiou    +886-2-23123456 ext 71737    ivyntuh@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03695029     History of Changes
Other Study ID Numbers: 201010078M
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Tenofovir
Hepatitis A
Herpesviridae Infections
Hepatitis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
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