An interventional study of TAF group and TDF group in Hepatitis B, sponsored by Guangzhou 8th People's Hospital. Recruiting at 10 sites in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by Guangzhou 8th People's Hospital · Not applicable, Interventional, and Prevention
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Among 21 studies testing tenofovir alafenamide in Hepatitis B — 10 open to participants now, 12 under way, 1 of them phase 3. tenofovir alafenamide · Hepatitis B.
Among the 21 studies testing tenofovir alafenamide in Hepatitis B, this one is the 4th largest by planned enrollment, is one of 4 that started in 2025, is one of 5 with no phase, reaches primary completion later than 9 of the 11 other live ones, and was the 17th registered.
1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →10 of the 21 studies testing tenofovir alafenamide in Hepatitis B are open now, in 3 countries. Recruiting first, the newest first:
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 18–65
Taichung Veterans General Hospital · Sites in Taiwan
Ages 20+
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 12–65
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 20–40 · Women only
The Third Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 20–40 · Women only
By country, each count listing its studies:
tenofovir alafenamide: first FDA approval 2015 (GENVOYA), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →
Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 20 Years to 40 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 210 is above the median of 145 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 120 across the 21 interventional studies. Of the 4 that completed or were terminated, 2 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 21 have an industry lead sponsor. The 10 most frequent:
Guangzhou 8th People's Hospital is the lead sponsor of 17 studies on the registry; 11 are open to participants now.
Guangzhou 8th People's Hospital has 2 studies filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
3 of the studies testing tenofovir alafenamide in Hepatitis B that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06221657Yonsei UniversityClinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment | 2026-12-01 |
| NCT07668934The Third Affiliated Hospital of Guangzhou Medical UniversityTAF in Early/Middle Pregnancy With CHB | 2027-03-30 |
| NCT07253220Sun Yat-sen UniversityTAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma | 2027-09-30 |
Add all 3 to your calendar (.ics) → With an account.
Among the 21 studies testing tenofovir alafenamide in Hepatitis B, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
Additionally, this study will also compare the incidence of congenital defects/malformations in infants born to mothers treated with tenofovir alafenamide and tenofovir disoproxil fumarate during the perinatal period to assess drug safety.
see summary
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without HBV treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Drug: TAF group
The mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without HBV treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Drug: TDF group
Pregnant women will start TAF treatment (25 mg tablet taken orally once daily) from 28 weeks of gestation until delivery. After that, they will be randomly assigned to two subgroups among postpartum mothers without treatment indications: one subgroup will stop treatment, while the other subgroup will continue with an additional 12 weeks of TAF treatment. The mothers and their infants will be followed up at 28 weeks postpartum. Infants will receive the hepatitis B vaccine and HBIG within 12 hours after birth, as well as booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Also known as: TAF
The mother will start receiving TDF treatment (300 mg tablet taken orally once daily) at 28 weeks of pregnancy until delivery. After that, mothers without treatment indications will be randomly assigned to two subgroups: one subgroup will stop treatment, while the other subgroup will receive an additional 12 weeks of TDF treatment. Infants will be vaccinated with the hepatitis B vaccine and HBIG within 12 hours after birth, as well as receive booster doses of the hepatitis B vaccine at 4 weeks and 24 weeks.
Also known as: TDF
The mother-to-child transmission rate of HBV
Compare the difference in HBV mother-to-infant transmission rates between pregnant women receiving TAF treatment and vaccinating their infants with hepatitis B vaccine and HBIg, and those receiving TDF treatment with the same vaccination for their infants. Here, the mother-to-infant transmission rate is defined as the proportion of infants in the experimental group who have serum HBV DNA \>20 IU/mL and are HBsAg positive at 28 weeks of age among all live births.
Time frame: 28 weeks
Congenital defects/malformations in infants
Determine the incidence of congenital defects/malformations in infants born to mothers treated with TAF and TDF during the perinatal period, and then conduct a comparative analysis of these data.
Time frame: 28 weeks
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL at the time of delivery will be used as a key secondary efficacy endpoint to evaluate the extent of HBV DNA reduction in mothers receiving TDF/TAF treatment.
Time frame: 12 weeks
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion during the study period was used as a secondary efficacy endpoint, and comparisons were made between the two groups.
Time frame: 36 weeks
ALT levels during or after TDF/TAF treatment
Observe the proportion of mothers with elevated ALT levels during or after TDF/TAF treatment (i.e., levels 5.1 to 10 times the upper limit of normal) or severe ALT elevation (levels more than 10 times the upper limit of normal), and conduct stratified and subgroup analyses after discontinuation of TDF/TAF (at delivery or at 12 weeks postpartum).
Time frame: 36 weeks
Renal function parameters of pregnant women
Summarize the percentage changes in renal function parameters (especially the decline in renal function indicators) of pregnant women in each group during and after antiviral treatment, and analyze the differences between the two groups.
Time frame: 36 weeks
Adverse events (including obstetric complications and laboratory abnormalities)
Summarize the percentage of mothers or infants experiencing adverse events (including obstetric complications and laboratory abnormalities) during the comparative study period, and analyze the differences between the two groups.
Time frame: 36 weeks
Proportion of two groups that discontinued treatment due to adverse events
Summarize the comparison of the proportion of two groups that discontinued treatment due to adverse events, and evaluate the differences in tolerance and medication adherence to TDF/TAF therapy.
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Use the 36-Item Short Form Health Survey (SF-36) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF).The SF-36 scores range from 0 to 100, with higher scores indicating a better quality of life.
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Use he Chronic Liver Disease Questionnaire (CLDQ) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF). The CLDQ is scored between 29 and 203, where increased scores reflect improved well-being.
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Use Patient Health Questionnaire-9 (PHQ-9) to elucidate the differences in quality of life between pregnant women treated with Tenofovir Disoproxil Fumarate (TDF) and those receiving Tenofovir Alafenamide (TAF). The PHQ-9 is scored from 0 to 27, with lower scores signifying a higher quality of life.
Time frame: 36 weeks
HBV DNA levels below 20 IU/mL
Summarize the percentage difference in HBV DNA levels below 20 IU/mL during delivery between the two groups of pregnant women.
Time frame: 12 weeks
Placental abnormalities
Evaluate and compare the percentage of mothers with placental abnormalities in the two groups.
Time frame: 12 weeks
Change in bone mineral density
Evaluate the percentage of change (especially decline) in bone mineral density (BMD) among maternal groups during antiviral treatment and after the treatment ends.
Time frame: 36 weeks
Depression, MASLD, or liver fibrosis
Evaluate the percentage of mothers with depression, MASLD, or liver fibrosis in each group before using TAF/TDF, during antiviral treatment, and after treatment.
Time frame: 36 weeks
Plan to share: Yes — The investigators are committed to the responsible sharing of anonymized Individual Patient Data (IPD) with qualified external researchers upon request or as required by law and/or regulation, based on the following criteria: Nature of the Request: The specific details and objectives of the data request will be reviewed to ensure alignment with ethical standards and research integrity. Merit of the Proposed Research: The proposed research's potential scientific value and contribution to the broader scientific community will be evaluated. Priority will be given to research that addresses significant clinical or scientific questions. Availability of the Data: The feasibility of sharing the requested data, considering any technical, legal, or logistical constraints, will be assessed. Intended Use of the Data: The intended use of the data will be scrutinized to ensure it is appropriate
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2028, 35 months after the start.
Of 62 non-industry interventional studies with no phase under Hepatitis B, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 35 months is above that.
Counting every sponsor, half of 68 studies reached it within 29 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Tenofovir alafenamide
Guangzhou 8th People's Hospital