Hepatitis B InfectionPhase 4NCT03476083
Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission
A Phase 4 study testing Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. in people with Hepatitis B Infection and Congenital Malformation, run by New Discovery LLC at 7 sites in China.
Trial summary
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Hepatitis B Infection, Congenital Malformation, Birth Defect
- What is being tested?
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 7 sitesChina
- Study dates
- 10 Jun 2018to May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069
Hua Zhang, MD, +86-13717850635, 13717850635@163.com
Huaibin Zou, MD, +86-13720084736, zhbin03@126.com
- Recruiting
Southwest Hospital
Chongqing, Chongqing Municipality, 400038
Jie Wang, MD, +86-15826122759, 876468834@qq.com
Shilian Li, MD, +86-15223423922, cqmu032@163.com
- Recruiting
Guangzhou Women and Children's Medical Center, Guangzhou Medical University
Guangzhou, Guangdong, 510623
Jinjuan Wu, MD, +86-13632446716, 14867150@qq.com
Thomas Q Zheng, MD, +86-18902268420, zhengqintian@yahoo.com
- Recruiting
The Third People's Hospital of Shenzhen
Shenzhen, Shenzhen, 518112
Liuqing Yang, MD, +86-13352983979, 350281813@qq.com
Yanjie Li, MD, +86-15096103342, 1129404985@qq.com
- Recruiting
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050021
Hongxia Tian, MD, +86-17332925370, 2631238023@qq.com
Suwen Li, MD, +86-13363876968, lisuwen158311@163.com
- Recruiting
Shijiazhuang Maternal and Child Health Care Hospital
Shijiazhuang, Hebei, 050051
Cuili Yang, MD, +86-18731160875, yangcuili0821@163.com
Jing Liu, MD, +86-15032791700, liujingteti@163.com
- Recruiting
Department of Infectious Diseases, the First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Taotao Yan, MD, +86-18691485175, 437550036@qq.com
Yingren Zhao, MD, +86-13509187086, zhaoyingren@mail.xjtu.edu.cn
About this study
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
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection. However, hepatitis B infection due to immunoprophylaxis failure often occurs in approximately 10% of infants who are born to highly viremic mothers with HBeAg-positive. Maternal HBV DNA > 200,000 IU/mL is the major independent risk for mother-to-child transmission (MTCT). A recent randomized controlled trial has shown that Tenofovir Disoproxil Fumarate (TDF) use during the third trimester of pregnancy could safely reduce the rate of MTCT with few adverse effects when combined with the administration of the standard immunoprophylaxis to the infants. However, HBIg is expensive and not available in many developing countries, resulting approximately 30% of infant infection when they received only HBV vaccination. The present study aims to investigate if highly viremic mothers who are treated with TDF from the second trimester to delivery in combination of infant's standard series of HBV vaccinations (omission of HBIg) have a comparable MTCT rates, when compared to those of mothers who receive TDF at the third trimester in combination of infant's standard HBV vaccinations and a birth dose of HBIg.
Read the detailed description
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.
- Being tested
- Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.
- Keywords
- Mother to Child Transmission, Hepatitis B Infection, Congenital Defects or Malformation, Hepatitis B Vaccine, Hepatitis B Immunoglobulin, Pregnancy, Antiviral Treatment
- Medical subject headings
- Hepatitis B, Congenital Abnormalities, Viremia, Persistent Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.Drug
Also called HBIg 200 IU im for infants in the group B, HBV vaccine 10 ug im for all infants
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. |
| Group B | Active comparator | 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. Receives: Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment on the proportion of infants who are infected with hepatitis B at the age of 28 weeks in the two groups
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.
Measured: From the date of birth to age of 28 weeks.
Secondary outcomes (5)
Assessment on congenital defects and/or malformation rates in each infant group for comparison
Congenital defects and/or malformation rates are defined as the proportion of infants with the aforementioned abnormalities discovered during the study period.
Measured: From the date of birth to age of 28 weeks.
Assessment on the reduction of maternal HBV DNA levels at delivery
Assess the reduction of maternal HBV DNA levels at delivery when compared to the baseline before initiating TDF.
Measured: From the date of randomization until delivery.
Maternal serological outcomes during the study: Percentage of mothers who loss/seroconversion of HBsAg or/and HBeAg during the study
Assess the percentage of mothers who loss/seroconversion of HBsAg or/and HBeAg during the study.
Measured: From the date of randomization until postpartum week 28.
Adverse events of both mothers and infants
Assess the percentage of mothers or infants who have adverse events during the study.
Measured: From the date of screening until postpartum week 28.
Tolerability of TDF therapy: Percentage of mothers who discontinue on TDF therapy due to the adverse event(s) during the study
Assess the percentage of mothers who discontinue on TDF therapy due to the adverse event(s) during the study.
Measured: From the date of randomization until delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start10 Jun 2018
- Primary completionMay 2021 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Discovery LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Calvin Q Pan, MD, Study chair, Leading Principle Investigator, NYU Langone Health, NYU School of Medicine, NYErhei Dai, MD, Study director, The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei Province, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476083
- Sponsor's protocol ID
- US-G10-P616
- Other IDs
- (2018) 462 No: HGRSL20180412
- Status last verified
- Dec 2019
- First submitted
- 18 Mar 2018
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ott JJ, Stevens GA, Wiersma ST. The risk of perinatal hepatitis B virus transmission: hepatitis B e antigen (HBeAg) prevalence estimates for all world regions. BMC Infect Dis. 2012 Jun 9;12:131. doi: 10.1186/1471-2334-12-131.
PubMed 22682147Pan CQ, Duan ZP, Bhamidimarri KR, Zou HB, Liang XF, Li J, Tong MJ. An algorithm for risk assessment and intervention of mother to child transmission of hepatitis B virus. Clin Gastroenterol Hepatol. 2012 May;10(5):452-9. doi: 10.1016/j.cgh.2011.10.041. Epub 2011 Nov 9.
PubMed 22079509Pande C, Sarin SK, Patra S, Kumar A, Mishra S, Srivastava S, Bhutia K, Gupta E, Mukhopadhyay CK, Dutta AK, Trivedi SS. Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial. J Viral Hepat. 2013 Nov;20(11):801-10. doi: 10.1111/jvh.12102. Epub 2013 Apr 23.
PubMed 24168259Lee LY, Aw MM, Saw S, Rauff M, Tong PY, Lee GH. Limited benefit of hepatitis B immunoglobulin prophylaxis in children of hepatitis B e antigen-negative mothers. Singapore Med J. 2016 Oct;57(10):566-569. doi: 10.11622/smedj.2015194. Epub 2015 Dec 29.
PubMed 26778725Machaira M, Papaevangelou V, Vouloumanou EK, Tansarli GS, Falagas ME. Hepatitis B vaccine alone or with hepatitis B immunoglobulin in neonates of HBsAg+/HBeAg- mothers: a systematic review and meta-analysis. J Antimicrob Chemother. 2015 Feb;70(2):396-404. doi: 10.1093/jac/dku404. Epub 2014 Oct 31.
PubMed 25362571Pan 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.
PubMed 27305192Pan, C. Q.; Chang, T. T.; Bae, S. H.; Brunetto, M.; Coffin, C.; Lau, A.; Mo, S.; Flaherty, J. F.; Gaggar, A.; Subramanian, G. M.; Nguyen, M. H.; Gurel, S.; Thompson, A.; Gane, E. J. Viral kinetics in women of child bearing potential with chronic hepatitis B virus following treatment with tenofovir alafenamide or tenofovir disoproxil fumarate. J Hepatol. 2017;66 S258-S259.
Pan CQ, Dai E, Mo Z, Zhang H, Zheng TQ, Wang Y, Liu Y, Chen T, Li S, Yang C, Wu J, Chen X, Zou H, Mei S, Zhu L. Tenofovir and Hepatitis B Virus Transmission During Pregnancy: A Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):390-399. doi: 10.1001/jama.2024.22952.
PubMed 39540799
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03476083
- Acronym / sponsor ID
- US-G10-P616
- Keywords
- Mother to Child Transmission, Hepatitis B Infection, Congenital Defects or Malformation, Hepatitis B Vaccine, Hepatitis B Immunoglobulin, Pregnancy, Antiviral Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- New Discovery LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunoprophylaxis with two hepatitis B vaccinations following the hepatitis B immune globulin (HBIg) and hepatitis B vaccine at birth is largely effective in protecting infants from hepatitis B virus (HBV) infection. However, hepatitis B infection due to immunoprophylaxis failure often occurs in approximately 10% of infants who are born to highly viremic mothers with HBeAg-positive. Maternal HBV DNA > 200,000 IU/mL is the major independent risk for mother-to-child transmission (MTCT). A recent randomized controlled trial has shown that Tenofovir Disoproxil Fumarate (TDF) use during the third trimester of pregnancy could safely reduce the rate of MTCT with few adverse effects when combined with the administration of the standard immunoprophylaxis to the infants. However, HBIg is expensive and not available in many developing countries, resulting approximately 30% of infant infection when they received only HBV vaccination. The present study aims to investigate if highly viremic mothers who are treated with TDF from the second trimester to delivery in combination of infant's standard series of HBV vaccinations (omission of HBIg) have a comparable MTCT rates, when compared to those of mothers who receive TDF at the third trimester in combination of infant's standard HBV vaccinations and a birth dose of HBIg.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.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. |
| Group B | Active comparator | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.Also: HBIg 200 IU im for infants in the group B, HBV vaccine 10 ug im for all infantsAll 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. | Drug | Group A, Group B |
Primary outcome
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.
5 secondary outcomes
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.
Assessment on the reduction of maternal HBV DNA levels at delivery
Time frame: From the date of randomization until delivery.
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.
Adverse events of both mothers and infants
Time frame: From the date of screening until postpartum week 28.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 22682147Ott JJ, Stevens GA, Wiersma ST. The risk of perinatal hepatitis B virus transmission: hepatitis B e antigen (HBeAg) prevalence estimates for all world regions. BMC Infect Dis. 2012 Jun 9;12:131. doi: 10.1186/1471-2334-12-131.
- Background: PubMed 22079509Pan CQ, Duan ZP, Bhamidimarri KR, Zou HB, Liang XF, Li J, Tong MJ. An algorithm for risk assessment and intervention of mother to child transmission of hepatitis B virus. Clin Gastroenterol Hepatol. 2012 May;10(5):452-9. doi: 10.1016/j.cgh.2011.10.041. Epub 2011 Nov 9.
- Background: PubMed 24168259Pande C, Sarin SK, Patra S, Kumar A, Mishra S, Srivastava S, Bhutia K, Gupta E, Mukhopadhyay CK, Dutta AK, Trivedi SS. Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial. J Viral Hepat. 2013 Nov;20(11):801-10. doi: 10.1111/jvh.12102. Epub 2013 Apr 23.
- Background: PubMed 26778725Lee LY, Aw MM, Saw S, Rauff M, Tong PY, Lee GH. Limited benefit of hepatitis B immunoglobulin prophylaxis in children of hepatitis B e antigen-negative mothers. Singapore Med J. 2016 Oct;57(10):566-569. doi: 10.11622/smedj.2015194. Epub 2015 Dec 29.
- Background: PubMed 25362571Machaira M, Papaevangelou V, Vouloumanou EK, Tansarli GS, Falagas ME. Hepatitis B vaccine alone or with hepatitis B immunoglobulin in neonates of HBsAg+/HBeAg- mothers: a systematic review and meta-analysis. J Antimicrob Chemother. 2015 Feb;70(2):396-404. doi: 10.1093/jac/dku404. Epub 2014 Oct 31.
- Background: PubMed 27305192Pan 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.
- BackgroundPan, C. Q.; Chang, T. T.; Bae, S. H.; Brunetto, M.; Coffin, C.; Lau, A.; Mo, S.; Flaherty, J. F.; Gaggar, A.; Subramanian, G. M.; Nguyen, M. H.; Gurel, S.; Thompson, A.; Gane, E. J. Viral kinetics in women of child bearing potential with chronic hepatitis B virus following treatment with tenofovir alafenamide or tenofovir disoproxil fumarate. J Hepatol. 2017;66 S258-S259.
- Derived from this study: PubMed 39540799Pan CQ, Dai E, Mo Z, Zhang H, Zheng TQ, Wang Y, Liu Y, Chen T, Li S, Yang C, Wu J, Chen X, Zou H, Mei S, Zhu L. Tenofovir and Hepatitis B Virus Transmission During Pregnancy: A Randomized Clinical Trial. JAMA. 2025 Feb 4;333(5):390-399. doi: 10.1001/jama.2024.22952.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvin Q Pan, MD study chair
Leading Principle Investigator, NYU Langone Health, NYU School of Medicine, NY
Erhei Dai, MD study director
The Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei Province, China
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily. in people with Hepatitis B Infection and Congenital Malformation, run by New Discovery LLC at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Chen, MD (+86-13363887189, 13363887189@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03476083, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.