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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01312012
First received: January 20, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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. This is a 3.5 year study. The clinical trials will screen 300 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 100~120 pregnant women with high HBV viral load (>10^8 copies/mL) will be recruited in the study; including 65-55 subjects treated with Tenofovir 300 mg daily starting from 30-32 weeks of gestation (3rd trimester) and continued to 1 month after delivery; and 45-55 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 8 weeks after treatment. The results of the present study will provide potentially applicable methods for reducing mother-to-infant HBV transmission.


Condition Intervention Phase
Hepatitis B Virus Infection, Pregnancy
Drug: antiviral therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • child-HBsAg [ Time Frame: 6 months after delivery ] [ Designated as safety issue: No ]
    serum status of HBsAg of the infants at 6 months old( >180 days).


Secondary Outcome Measures:
  • 1. child HBsAg; 2.maternal viral load, HBeAg, and ALT [ Time Frame: 1. 12 months after delivery (infant); 2. 8 weeks after taking medication (mothers) ] [ Designated as safety issue: No ]
    1. Serum status of HBsAg of the infants at 12 months old, to see whether this child indeed becomes a chronic carrier of HBV.
    2. The change of maternal viral load, HBeAg, and liver function, at 8 weeks after medication.


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312012

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Mei-Hwei Chang, PhD National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01312012     History of Changes
Other Study ID Numbers: 201010078M
Study First Received: January 20, 2011
Last Updated: April 11, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
hepatitis B virus,mother-infant transmission, nucleoside analog,pregnant women

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Virus Diseases
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014