UnknownPhase 4

Tenofovir Disoproxil Fumarate in Combination of Hepatitis B Vaccine for Preventing Hepatitis B Vertical Transmission

China280 participantsStarted 2018-06-10

Plain-language 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. 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.

Who can participate

Age range

20 Years – 35 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment on the proportion of infants who are infected with hepatitis B at the age of 28 weeks in the two groups

Timeframe: From the date of birth to age of 28 weeks.

Trial details

NCT IDNCT03476083

SponsorNew Discovery LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05

Contact for this trial

Xiuli Chen, MD

+86-13363887189 13363887189@163.com

View on ClinicalTrials.gov More Hepatitis B Infection trials