Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B
NCT ID: NCT04211805
Last Updated: 2020-12-29
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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UNKNOWN
450 participants
OBSERVATIONAL
2020-01-27
2021-09-30
Brief Summary
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Detailed Description
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All aforementioned clinical parameters will be extracted from mothers at the following timepoints for assessment: the baseline, i.e. the start of TAF/TDF treatment, gestational weeks 28, 32, 36, on delivery, and at postpartum weeks 24-28. For the infant, information from two timepoints, at birth and at infant age of 28 weeks, will be collected. This information regarding the infant will include the physical parameters weight, height, head circumference, HBV DNA levels, HBV serological status, if they received hepatitis B immunoglobin (HBIg), if they received the complete series of HBV vaccine. All relevant information regarding the patient will be logged into a password-protected computer for primary and secondary analysis.
Group A: 225 participating mothers will receive TAF (oral 25 mg tablet daily) starting at gestational week 24-28 of pregnancy and continue until delivery. The mothers will be followed together with their infants until postpartum week 28.Infants will receive hepatitis B vaccine plus HBIg at birth (within 12 hours) and additional hepatitis B vaccine at the age of week 4 and week 24. Group B: 225 participating mothers will receive TDF (oral 300 mg tablet daily) starting at gestational week 24-28 of pregnancy and continue until delivery. Patients in group B will have similar follow-up schedules as those in the Group A. Infants will receive hepatitis B vaccine plus HBIg at birth (within 12 hours) and additional hepatitis B vaccine at the age of week 4 and week 24.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm (A) TAF Group Comprised of Patients from 11 Centers.
225 consecutive patients will be treated with local standard of care. The antiviral drug Tenofovir Alafenamide (TAF) will be used to treat highly viremic chronic hepatitis B mothers from the gestational week 24-28 of pregnancy to delivery of infant at eleven centers across the People's Republic of China (PRC). Infants will receive hepatitis B vaccine plus HBIg at birth (within 12 hours) and additional hepatitis B vaccine at the age of week 4 and week 24.
Tenofovir Alafenamide 25 MG for arm (A)
Tenofovir Alafenamide (TAF) will be provided, 25 mg Per Oral daily.
Arm (B) TDF Group Comprised of Patients from 11 Centers.
225 consecutive patients will be treated with local standard of care. The antiviral drug Tenofovir Disoproxil Fumarate (TDF) will be used to treat highly viremic chronic hepatitis B mothers from the gestational week 24-28 of pregnancy to delivery of infant at eleven centers across the People's Republic of China (PRC). Infants will receive hepatitis B vaccine plus HBIg at birth (within 12 hours) and additional hepatitis B vaccine at the age of week 4 and week 24.
Tenofovir Disoproxil Fumarate 300mg for arm (B)
Tenofovir Disoproxil Fumarate (TDF) will be provided, 300 mg Per Oral daily.
Interventions
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Tenofovir Alafenamide 25 MG for arm (A)
Tenofovir Alafenamide (TAF) will be provided, 25 mg Per Oral daily.
Tenofovir Disoproxil Fumarate 300mg for arm (B)
Tenofovir Disoproxil Fumarate (TDF) will be provided, 300 mg Per Oral daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Gestational age between 12-14 weeks (The screening on patients can be started at gestational week 12).
3. Documented compensated and stable chronic hepatitis B defined by all of the following:
* HBsAg persistently positive \> 6 months.
* Clinical history, physical findings, and test results are compatible with compensated chronic hepatitis B.
4. Detectable maternal serum HBsAg and HBeAg at the screening visit.
5. Maternal serum HBV DNA levels exceeding 200,000 IU/mL by the COBAS Amplicor HBV PCR assay at screening visits.
6. Patient is willing and able to comply with the study drug regimen and all other study requirements. Patient is also willing to prevent another pregnancy in 28 weeks after delivery of the current baby.
7. Patient and her husband (both father and mother of the child) understand the risk and are willing to have the mother participating in the study. The mother must be willing and able to provide written informed consent to participate in the study.
Exclusion Criteria
1. Creatinine clearance \<100 mL/min (using the Cockcroft-Gault method based on serum creatinine and ideal body weight) or hypo-phosphoremia (below normal range).
2. History of renal events on adefovir or history of resistance to adefovir.
3. Hemoglobin \<8 g/dL, or neutrophil count \<1000/uL, or ALT \>5 times ULN, or total bilirubin \>2 mg/dL; or albumin \<25gm/L, or abnormal creatinine level, or abnormal BUN levels.
4. History of abortion, or congenital malformation, or child infected with HBV in a prior pregnancy.
5. Biological father of the child (current pregnancy) has CHB.
6. Significant renal, cardiovascular, pulmonary, or neurological disease that may impact the subject's participation in the study as per the opinion of the investigator.
18 Years
FEMALE
No
Sponsors
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New Discovery LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Calvin Pan, MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital, Capital Medical University; NYU Langone Health, NY, USA
Locations
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Pingdingshan Hospital of Chongqing Public Health Medical Treatment Center
Shapingba, Chongqing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
The Third Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
The Fourth Hospital of Harbin Medical University
Harbin, Heilonjiang, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Ganzhou Fifth People's Hospital
Ganzhou, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shanghai Public Health Clinical Center, Fudan University
Zhujing, Shanghai Municipality, China
Yuyao People's Hospital of Zhejiang Province
Yuyao, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Yangsu Tu, MD
Role: primary
Qi Zheng, MD
Role: primary
Xiao Y Lin, MS
Role: backup
Bei-Bei Zhu, MD
Role: primary
Sai-Nan Pi, Ph.D
Role: backup
Jiao Wang, MD
Role: primary
Furong Xiao, MD
Role: backup
Lihua Cao, MD
Role: primary
Shouyun Wang, MD
Role: backup
Lei Yu, MD
Role: primary
Linying Zhu, MD
Role: backup
Yan Huang, MD
Role: primary
Zebing Huang, MD
Role: backup
Huizhen Hong
Role: primary
Lijuan Long, MD
Role: backup
Qiuju Sheng, MD
Role: primary
Xiaoguang Dou, MD
Role: backup
Min-min Sheng, MD
Role: primary
Min Liu, MD
Role: backup
Lou Jian Jun, MD
Role: primary
Yu Hai Yun, MD
Role: backup
References
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Xu WM, Cui YT, Wang L, Yang H, Liang ZQ, Li XM, Zhang SL, Qiao FY, Campbell F, Chang CN, Gardner S, Atkins M. Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: a multicentre, randomized, double-blind, placebo-controlled study. J Viral Hepat. 2009 Feb;16(2):94-103. doi: 10.1111/j.1365-2893.2008.01056.x. Epub 2008 Oct 8.
Zou H, Chen Y, Duan Z, Zhang H. Protective effect of hepatitis B vaccine combined with two-dose hepatitis B immunoglobulin on infants born to HBsAg-positive mothers. PLoS One. 2011;6(10):e26748. doi: 10.1371/journal.pone.0026748. Epub 2011 Oct 28.
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.
Jourdain G, Ngo-Giang-Huong N, Harrison L, Decker L, Khamduang W, Tierney C, Salvadori N, Cressey TR, Sirirungsi W, Achalapong J, Yuthavisuthi P, Kanjanavikai P, Na Ayudhaya OP, Siriwachirachai T, Prommas S, Sabsanong P, Limtrakul A, Varadisai S, Putiyanun C, Suriyachai P, Liampongsabuddhi P, Sangsawang S, Matanasarawut W, Buranabanjasatean S, Puernngooluerm P, Bowonwatanuwong C, Puthanakit T, Klinbuayaem V, Thongsawat S, Thanprasertsuk S, Siberry GK, Watts DH, Chakhtoura N, Murphy TV, Nelson NP, Chung RT, Pol S, Chotivanich N. Tenofovir versus Placebo to Prevent Perinatal Transmission of Hepatitis B. N Engl J Med. 2018 Mar 8;378(10):911-923. doi: 10.1056/NEJMoa1708131.
Wiseman E, Fraser MA, Holden S, Glass A, Kidson BL, Heron LG, Maley MW, Ayres A, Locarnini SA, Levy MT. Perinatal transmission of hepatitis B virus: an Australian experience. Med J Aust. 2009 May 4;190(9):489-92. doi: 10.5694/j.1326-5377.2009.tb02524.x.
Other Identifiers
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CN-P919-2020
Identifier Type: -
Identifier Source: org_study_id