Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
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ClinicalTrials.gov Identifier: NCT03476083 |
Recruitment Status :
Recruiting
First Posted : March 23, 2018
Last Update Posted : December 12, 2019
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Condition or disease | Intervention/treatment | Phase |
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Hepatitis B Infection Congenital Malformation Birth Defect Viremia Chronic Infection | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. | Phase 4 |
This is a multicenter, prospective, randomized, open-label and parallel two arm study starting from week 14-16 of pregnancy to post-partum week 28. The enrollment from approximately 7 centers will be in blocks for sample balance. By using the randomized table, 280 HBeAg-positive pregnant women with chronic hepatitis B (CHB) will be randomized in a 1:1 ratio in to two arms. Group assignments will be also stratified by the maternal HBV DNA levels >9 log10 versus ≤ 9 log10 IU/mL.
Group A: This is the experimental group. Participating mothers will receive TDF (oral 300 mg tablet daily) starting at gestational weeks 14-16 and continue until delivery. The mothers will be followed together with their infants until postpartum week 28. Infants will receive hepatitis B vaccine at birth (within 12 hours) and additional hepatitis B vaccine at the age of week 4 and week 24. HBIg will be omitted for the infants in this group. However, the birth dose of HBIg will be provided to infants born to mothers who have poor control of maternal viremia (i.e. the levels of HBV DNA >200,000 IU/mL before delivery). Group B: This is the comparative group. Participating mothers will receive TDF (oral 300 mg tablet daily) starting at gestational weeks 28 and continue until delivery. Patients in group B will have similar follow-up schedules as those in the experimental group. 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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine With the Omission of Immune Globulin to Prevent Hepatitis B Transmission in Mother With High Viral Load: A Multi-Center, Prospective, Randomized and Open-Label Study |
Actual Study Start Date : | June 10, 2018 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | May 2024 |

Arm | Intervention/treatment |
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Experimental: Group A
This is the experimental group. Participating mothers will receive Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily, starting at gestational weeks 14-16 and continue until delivery. The mothers will be followed together with their infants until postpartum week 28. Infants will receive hepatitis B vaccine at birth and additional hepatitis B (HBV) vaccine at the age of week 4 and week 24. HBIg will be omitted for the infants in this group.
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Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
All mothers will receive TDF therapy. However, group A will initiate TDF at the gestational week of 14-16, while group B will initiate TDF at the gestational week of 28. All infants will receive a series of three hepatitis B vaccines (at birth, age of weeks 4 and 24). In addition, the infants in the group B will receive HBIg injection at birth.
Other Names:
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Active Comparator: Group B
This is the comparative group. Participating mothers will receive Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily, starting at gestational weeks 28 and continue until delivery. Patients in group B will have similar follow-up schedules as those in the experimental group. Infants will receive hepatitis B vaccine plus HBIg at birth and additional hepatitis B vaccine at the age of week 4 and week 24.
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Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
All mothers will receive TDF therapy. However, group A will initiate TDF at the gestational week of 14-16, while group B will initiate TDF at the gestational week of 28. All infants will receive a series of three hepatitis B vaccines (at birth, age of weeks 4 and 24). In addition, the infants in the group B will receive HBIg injection at birth.
Other Names:
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- Assessment on the proportion of infants who are infected with hepatitis B at the age of 28 weeks in the two groups [ Time Frame: From the date of birth to age of 28 weeks. ]Compare MTCT rates between the two study groups and demonstrate non-inferiority in efficacy. MTCT rate is defined as the proportion of infants with serum HBV DNA >20 IU/mL and/or HBsAg positivity at 28 weeks of age.
- Assessment on congenital defects and/or malformation rates in each infant group for comparison [ Time Frame: From the date of birth to age of 28 weeks. ]Congenital defects and/or malformation rates are defined as the proportion of infants with the aforementioned abnormalities discovered during the study period.
- Assessment on the reduction of maternal HBV DNA levels at delivery [ Time Frame: From the date of randomization until delivery. ]Assess the reduction of maternal HBV DNA levels at delivery when compared to the baseline before initiating TDF.
- Maternal serological outcomes during the study: Percentage of mothers who loss/seroconversion of HBsAg or/and HBeAg during the study [ Time Frame: From the date of randomization until postpartum week 28. ]Assess the percentage of mothers who loss/seroconversion of HBsAg or/and HBeAg during the study.
- Adverse events of both mothers and infants [ Time Frame: From the date of screening until postpartum week 28. ]Assess the percentage of mothers or infants who have adverse events during the study.
- Tolerability of TDF therapy: Percentage of mothers who discontinue on TDF therapy due to the adverse event(s) during the study [ Time Frame: From the date of randomization until delivery. ]Assess the percentage of mothers who discontinue on TDF therapy due to the adverse event(s) during the study.

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Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HBeAg-positive CHB mothers
- Age of 20-35 years old
- Serum HBV DNA levels > 200,000 IU/mL
- Gestational age between 12-14 weeks.
- Both mother and father of the child have the ability to understand and are willing to consent to the study.
Exclusion Criteria:
- Co-infection with (HIV)-1, or hepatitis A, C, D, E or sexual transmitted diseases (STD)
- History of abortion or congenital malformation in a prior pregnancy
- Treatment experience (except when antivirals were used for MTCT prevention in a previous pregnancy and discontinued >6 months prior to the current pregnancy)
- History of renal dysfunction; evidence of liver cancer or decompensation
- Estimated creatinine clearance (CLCr) <100 mL/min (using the Cockcroft-Gault method based on serum creatinine and ideal body weight)
- Hypo-phosphoremia; hemoglobin <8 g/dL; neutrophil count <1,000//μL; alanine aminotransferase >5 times upper limit of the normal; total bilirubin >2 mg/dL; albumin <25gm/L;
- Clinical signs of threatened miscarriage
- Ultrasonographic evidence of fetal deformity
- Concurrent treatment with nephrotoxic drugs, steroids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators;
- Recipient of solid organ or bone marrow transplant
- Significant renal, cardiovascular, pulmonary, neurological disease or other health conditions in the opinion of the investigator
- Fetus's biological father had CHB infection

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): NCT03476083
Contact: Xiuli Chen, MD | +86-13363887189 | 13363887189@163.com | |
Contact: Erhei Dai, MD | +86-13323119296 | daieh2008@126.com |
China, Beijing | |
Beijing Youan Hospital, Capital Medical University | Recruiting |
Beijing, Beijing, China, 100069 | |
Contact: Hua Zhang, MD +86-13717850635 13717850635@163.com | |
Contact: Huaibin Zou, MD +86-13720084736 zhbin03@126.com | |
Principal Investigator: Hua Zhang, MD | |
Sub-Investigator: Zhongping Duan, MD | |
China, Chongqing | |
Southwest Hospital | Recruiting |
Chongqing, Chongqing, China, 400038 | |
Contact: Jie Wang, MD +86-15826122759 876468834@qq.com | |
Contact: Shilian Li, MD +86-15223423922 cqmu032@163.com | |
Principal Investigator: Yuming Wang, MD | |
Sub-Investigator: Yangsu Tu, MD | |
China, Guangdong | |
Guangzhou Women and Children's Medical Center, Guangzhou Medical University | Recruiting |
Guangzhou, Guangdong, China, 510623 | |
Contact: Jinjuan Wu, MD +86-13632446716 14867150@qq.com | |
Contact: Thomas Q Zheng, MD +86-18902268420 zhengqintian@yahoo.com | |
Principal Investigator: Thomas Q Zheng, MD | |
Sub-Investigator: Ping He, MD | |
China, Hebei | |
The Fifth Hospital of Shijiazhuang | Recruiting |
Shijiazhuang, Hebei, China, 050021 | |
Contact: Hongxia Tian, MD +86-17332925370 2631238023@qq.com | |
Contact: Suwen Li, MD +86-13363876968 lisuwen158311@163.com | |
Principal Investigator: Erhei Dai, MD | |
Sub-Investigator: Suwen Li, MD | |
Shijiazhuang Maternal and Child Health Care Hospital | Recruiting |
Shijiazhuang, Hebei, China, 050051 | |
Contact: Cuili Yang, MD +86-18731160875 yangcuili0821@163.com | |
Contact: Jing Liu, MD +86-15032791700 liujingteti@163.com | |
Principal Investigator: Zhongfu Mo, MD | |
Sub-Investigator: Cuili Yang, MD | |
China, Shaanxi | |
Department of Infectious Diseases, the First Affiliated Hospital of Xi'an Jiaotong University | Recruiting |
Xi'an, Shaanxi, China, 710061 | |
Contact: Taotao Yan, MD +86-18691485175 437550036@qq.com | |
Contact: Yingren Zhao, MD +86-13509187086 zhaoyingren@mail.xjtu.edu.cn | |
Sub-Investigator: Tianyan Chen, MD | |
Principal Investigator: Yingren Zhao, MD | |
China, Shenzhen | |
The Third People's Hospital of Shenzhen | Recruiting |
Shenzhen, Shenzhen, China, 518112 | |
Contact: Liuqing Yang, MD +86-13352983979 350281813@qq.com | |
Contact: Yanjie Li, MD +86-15096103342 1129404985@qq.com | |
Principal Investigator: Yingxia Liu, MD | |
Sub-Investigator: Liuqing Yang, MD |
Study Chair: | Calvin Q Pan, MD | Leading Principle Investigator, NYU Langone Health, NYU School of Medicine, NY | |
Study Director: | Erhei Dai, MD | The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei Province, China |
Responsible Party: | New Discovery LLC |
ClinicalTrials.gov Identifier: | NCT03476083 |
Other Study ID Numbers: |
US-G10-P616 (2018) 462 No: HGRSL20180412 ( Other Identifier: Ministry of Science and Technology of China, HGRM Office ) |
First Posted: | March 23, 2018 Key Record Dates |
Last Update Posted: | December 12, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Mother to Child Transmission Hepatitis B Infection Congenital Defects or Malformation Hepatitis B Vaccine |
Hepatitis B Immunoglobulin Pregnancy Antiviral Treatment |
Infections Communicable Diseases Hepatitis A Hepatitis B Viremia Hepatitis Congenital Abnormalities Disease Attributes Pathologic Processes Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections |
RNA Virus Infections Blood-Borne Infections Hepadnaviridae Infections DNA Virus Infections Sepsis Systemic Inflammatory Response Syndrome Inflammation Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents |