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New treatment option for Hepatitis B
Official title Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
ClinicalTrials.gov ID: NCT06947356
What this study is testing
What is TAF group?
TAF group is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hepatitis b.
Also referred to as TAF.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main objective of this study is to compare the mother-to-infant transmission rates of hepatitis B between pregnant women receiving treatment with tenofovir alafenamide and those receiving treatment with tenofovir disoproxil fumarate, after administering the hepatitis B vaccine and hepatitis B immunoglobulin to their infants at birth. Investigators define the mother-to-infant transmission rate of hepatitis B as the proportion of infants who are HBsAg positive and have serum HBV DNA \>20 IU/mL at 28 weeks of age among all live births in the experimental group.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 40, women only
You may be able to join if
- Pregnant women aged between 20 and 40 years old
- Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
- Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results...
- HBsAg and HBeAg positive in maternal serum during screening
- PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
You likely can't join if
- Creatinine clearance \< 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia...
- History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
- Meeting one of the following criteria: hemoglobin \ 5 times the upper limit of normal, total bilirubin \> 20 mg/L, albumin \< 25 g/L, abnormal levels...
- Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with...
- The biological father of the current pregnancy has chronic hepatitis B.
- The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their...
See the full eligibility criteria
- Pregnant women aged between 20 and 40 years old
- Pregnancy duration between 20 to 28 weeks (screening for eligible patients can start from the 20th week of gestation)
- Clinically diagnosed with compensated chronic hepatitis B, HBsAg positive for more than 6 months, with clinical history, signs, and test results consistent with compensated chronic hepatitis B
- HBsAg and HBeAg positive in maternal serum during screening
- PCR testing shows maternal serum HBV DNA levels exceeding 200,000 IU/mL
- people voluntarily agree to undergo treatment according to the study design's drug treatment plan and all other research requirements, and patients consent to strictly avoid pregnancy within 28 weeks postpartum
- Patients and their husbands (the biological parents of the child) understand the risks and voluntarily participate in the study. The mother must participate voluntarily and sign a written informed consent document...
- Creatinine clearance \< 100 mL/min (calculated using the Cockcroft-Gault method based on serum creatinine and ideal body weight), or hypophosphatemia (below normal range).
- History of adverse renal reactions induced by Adefovir or history of Adefovir resistance.
- Meeting one of the following criteria: hemoglobin \ 5 times the upper limit of normal, total bilirubin \> 20 mg/L, albumin \< 25 g/L, abnormal levels of creatinine or urea nitrogen.
- Pregnant women with a history of miscarriage, history of giving birth to a child with congenital malformations, or history of fetal infection with hepatitis B virus.
- The biological father of the current pregnancy has chronic hepatitis B.
- The investigator assesses that the subject has significant kidney, cardiovascular, pulmonary, or neurological diseases that affect their participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Shijiazhuang, Hebei, China
- Changsha, Hunan, China
- Wenzhou, Zhejiang, China
- Beijing, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years to 40 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Shijiazhuang, Hebei, China; Changsha, Hunan, China; Wenzhou, Zhejiang, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.