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The Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test

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. Identifier: NCT01312012
Recruitment Status : Recruiting
First Posted : March 10, 2011
Last Update Posted : November 27, 2020
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:

Since the implementation of universal vaccination in 1984, the chronic HBV carier rate in our general population reduced from 15-20%, down to < 1% in the post-vaccination population. However, children born to HBeAg positive mothers still may be infected with HBV despite immunization. To further reducing the HBV infection in our people, strategies in reducing infection rate in this high risk group are mandatory. Previous small scale studies using lamivudine treatment in pregnant woman in the third trimester has proved effective in reducing children infection rate. The aims of the present study are to conduct a clinical trial in using Tenofovir (category B) to reduce mother-to-infant transmission, and to monitor the hepaitits B viral status and mother hepatitis occurrence. The clinical trials will screen cases of HBsAg positive pregnant women aged 20 to 40 years at gestational at 20-32 weeks. They will be tested for HBsAg and HBeAg. In whom both markers are positive, HBV viral load will be tested. An estimated 180 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 80-100 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 80-100 pregnant women are enrolled as controls with no drug given to the mother. The newborn babies are given with HBIG within 24 hours after delivery, and HBV vaccines at 0, 1 and 6 months. Maternal complete blood count (CBC) data tested in the first prenatal examination will be recorded. Plasma AST、ALT levels and HBV DNA are tested before Tenofovir treatment, 1 month after treatment, at the time of delivery, and at 1, 2, 4 and 6 months after delivery. HBsAg、HBeAg、anti-HBs and AST、ALT are tested in the children at day 1, 6 moths and 1 year after birth. The primary outcome is reduction of the HBsAg carrier rate of the children at 6 months of age. The secondary outcome is HBsAg carrier rate of the children at 12 months of age, the change of liver function, HBeAg, and viral load in pregnant mother after treatment.

A follow-up study for investigating safety of mothers and children that has been exposed to maternal tenofovir disoproxil fumarate (TDF) during pregnancy in reducing mother-to-infant hepatitis B virus (HBV) transmissions is conducted. The follow-up study included mother-children pairs 2-4 years after delivery of the children.

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Infection, Pregnancy Drug: antiviral therapy Phase 4

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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: Treatment
Official Title: The Effectiveness and Feasibility of Using Antiviral Therapy in Pregnant Women to Reduce Mother-to-infant Transmission of Hepatitis B Virus-drug Test and Follow-up Study
Study Start Date : January 2011
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: The effectiveness and feasibility, using antiviral therapy
Experimental: Subjects receive tenofovir disoproxil fumarate (TDF) oral use prior to delivery in pregnant women with positive serum HBeAg and HBsAg and high HBV DNA levels > 10^8copies / mL, to reduce the rate of mother to infant transmission of HBV infection, and also to monitor the safety of the therapy.
Drug: antiviral therapy
100-120 pregnant women seropositive for both HBeAg and HBsAg and with hepatitis B viral DNA level > 10 8 copies/mL. Among them, 55-65 pregnant women will receive TDF therapy 300 mg once daily, starting from the gestational age 30-32 (the 3rd trimester) until 4 weeks after delivery of the neonate under informed consent. The total treatment duration will be 3-4 months. Another 45-55 pregnant women with the same serum HBAg and HBsAg and HBV DNA status will be enrolled as the control group with no TDF therapy ( An open-labeled study)

No Intervention: Control
Subjects receive no intervention, but with blood tests for mothers and infants before and after delivery, as a comparative group to experimental arm.

Primary Outcome Measures :
  1. Child-HBsAg [ Time Frame: 6 months after delivery ]
    serum status of HBsAg of the infants at 6 months old( >180 days).

Secondary Outcome Measures :
  1. Child HBsAg [ Time Frame: 12 months after birth ]
    Serum HBsAg positivity of the infants at 12 months old, to see whether this child indeed becomes a chronic carrier of HBV.

  2. Children growth parameters [ Time Frame: 0-5 years after birth ]
    body weight and length Z score according to age

  3. Children HBV status [ Time Frame: 0-5 years after birth ]
    HBsAg and anti-HBs positivity rates

  4. Children serum biochemistry [ Time Frame: 0-5 years after birth ]
    Rates of abnormal levels of serum ALT(U/L), creatinine (mg/dL) and calcium (mmol/L)

  5. Maternal HBeAg seroconversion rate [ Time Frame: delivery to 5 years after delivery ]
    Maternal HBeAg seroconversion rate, the time of HBeAg (+) to convert to HBeAg(-) after delivery

  6. Maternal ALT elevation [ Time Frame: delivery to 5 years after delivery ]
    The extent (folds of upper limit of normal, ULN) of ALT elevation and duration.

  7. Maternal HBV DNA [ Time Frame: delivery to 5 years after delivery ]
    Change of levels of HBV DNA (log IU/mL) from baseline

  8. Children bone growth [ Time Frame: 2-5 years after birth ]
    comparisons of BAP levels(U/L) and bone density (DEXA) between control and treatment group

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

Inclusion Criteria:

- pregnant women in 30 to 32 weeks of gestation, with positive HBsAg and HBeAg,serum viral load above 8log10 copies per mL

Exclusion Criteria:

  • major systemic disease
  • Pregnant woman with infection of human immunodeficiency virus or hepatitis C virus
  • Pregnant woman is receiving any drug with antiviral activity or any form of drug therapy for hepatitis B virus
  • 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 identifier (NCT number): NCT01312012

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Contact: Mei-Hwei Chang, PhD 886-02-23123456 ext 71723
Contact: Huey-Ling Chen, PhD 886-02-23123456 ext 71722

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National Taiwan University Hospital Recruiting
Taipei, Taiwan, 10002
Contact: Mei-Hwei Chang, PhD    886+02-23123456 ext 71723   
Contact: Huey-Ling Chen, PhD    886+02-23123456 ext 71722   
Sub-Investigator: Chien Nan Lee, Doctor         
Sponsors and Collaborators
National Taiwan University Hospital
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Principal Investigator: Mei-Hwei Chang, PhD National Taiwan University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital Identifier: NCT01312012    
Other Study ID Numbers: 201010078M, 201507025RINC
First Posted: March 10, 2011    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: November 2020
Keywords provided by National Taiwan University Hospital:
hepatitis B virus,mother-infant transmission, nucleoside analog,pregnant women
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Herpesviridae Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents