Tenofovir in Late Pregnancy to Prevent Vertical Transmission of Hepatitis B Virus
NCT ID: NCT01488526
Last Updated: 2019-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2012-03-01
2018-06-28
Brief Summary
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Tenofovir Disoproxil (TDF), a pregnancy category B medication, reduces HBV DNA and normalizes serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. Two aspects on tenofovir use in pregnancy will be evaluated prospectively in this study:
1. The data on its tolerability and safety in HBeAg+ pregnant women with HBV DNA \> 6log10 copies/mL (or \> 200,000 IU/mL) during late pregnancy and infants.
2. Its efficacy in the reduction of HBV vertical transmission rate.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control arm: HBIG & vaccine for infants
Provide standard of care to mothers and standard immunoprophylaxis to their infants
No interventions assigned to this group
TDF treatment arm
tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum for mothers and standard immunoprophylaxis to their infants
TDF treatment
About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
Interventions
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TDF treatment
About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HBeAg+ CHB pregnant women
* gestational age between 30-32 weeks
* HBV DNA \> 6 log10 copies/mL (or \>200,000 IU/mL)
* both mother and father of the child are willing to consent for the study
Exclusion Criteria
* decompensated liver disease or significant co-morbidity
* history of abortion, or diagnosis of fetal defect, or congenital malformation in prior pregnancy
* antiviral used within six months prior to this pregnancy, or history of renal or tubular function impairment due to adefovir.
* requirement for other medication during pregnancy to manage other chronic disease(s) or concurrent treatment with immune-modulators, cytotoxic drugs, or steroids
* the biological father of the child had CHB
* clinical signs of threatened miscarriage in early pregnancy
* evidence of hepatocellular carcinoma
* maternal alanine aminotransferase (ALT) \> or = 5 x upper limit of normal (U/mL), or Total Bilirubin \> or = 2, or glomerular filtration rate (GFR) \< 100, or Albumin \< 25 g/L
* evidence of fetal deformity by ultrasound examination
* patient is participating other clinical study
20 Years
35 Years
FEMALE
No
Sponsors
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Gilead Sciences
INDUSTRY
New Discovery LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Calvin Q Pan, MD
Role: STUDY_CHAIR
Leading Principle Investigator, Division of Gastroenterology and Hepatology, NYU Langone Medical Center, New York
Zhongping Duan, MD
Role: STUDY_DIRECTOR
Capital Medical University
Shuqin Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Hepatobiliary Disease Hospital of Jilin Province, Jilin, China
Erhei Dai, MD
Role: PRINCIPAL_INVESTIGATOR
The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, China
Guorong Han, MD
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of the Southeast University, Nanjing, China
Huaihong Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Nanyang Central Hospital, Nanyang, Henan, China
Yuming Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Southwest Hospital, Chongqing, Chongqing, China
Locations
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Southwest Hospital
Chongqing, Chongqing Municipality, China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
Nanyang Central Hospital
Nanyang, Henan, China
The Second Affiliated Hospital of the Southeast University
Nanjing, Jiangsu, China
Hepatobiliary Disease Hospital of Jilin Province
Changchun, Jilin, China
Countries
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References
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Pan CQ, Dai E, Duan Z, Han G, Zhao W, Wang Y, Zhang H, Zhu B, Jiang H, Zhang S, Zhang X, Zou H, Chen X, Chen Y. Long-term safety of infants from mothers with chronic hepatitis B treated with tenofovir disoproxil in China. Gut. 2022 Apr;71(4):798-806. doi: 10.1136/gutjnl-2020-322719. Epub 2021 Mar 31.
Pan CQ, Duan Z, Dai E, Zhang S, Han G, Wang Y, Zhang H, Zou H, Zhu B, Zhao W, Jiang H; China Study Group for the Mother-to-Child Transmission of Hepatitis B. Tenofovir to Prevent Hepatitis B Transmission in Mothers with High Viral Load. N Engl J Med. 2016 Jun 16;374(24):2324-34. doi: 10.1056/NEJMoa1508660.
Other Identifiers
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IN-US 174-0174
Identifier Type: -
Identifier Source: org_study_id