Hepatitis BNCT06947356
Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads
A study testing TAF group and TDF group in people with Hepatitis B, run by Guangzhou 8th People's Hospital at 10 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hepatitis B
- What is being tested?
- TAF group and TDF group
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 10 sitesChina
- Study dates
- 3 May 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
- Subjects 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 before participating in the study.
Who cannot join
- 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 < 80 g/L, neutrophil count < 1000/μL, ALT > 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Not yet recruiting
Beijing You 'an Hospital, Capital Medical University
Beijing
Yunxia Zhu, +86 010-83997100, zyxno7@163.com
- Not yet recruiting
Xiangya Hospital, Central South University
Changsha, Hunan
Yan Huang, +86 0731-89753770, drhyan@163.com
- Recruiting
Guangzhou Eighth People's Hospital, Guangzhou Medical University
Guangzhou, Guangdong
Yujuan Guan, +86 13632293277, gz8hgyj@126.com
- Not yet recruiting
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong
Yanmin Jiang, +86 020-38076169
- Not yet recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University, Guangzhou
Guangzhou, Guangdong
Ouyang Shi, +86 020-85959246, ouyangshi@gzhmu.edu.cn
- Not yet recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Xingfei Pan, +86 020-81292826, panxing0125@163.com
- Not yet recruiting
Shenzhen Baoan Women's and Children's Hospital
Shenzhen, Guangdong
Yuanfang Zhu, +86 0755-27863999-8608, zhuyf1027@163.com
- Not yet recruiting
Shijiazhuang Maternity & Child Healthcare Hospital
Shijiazhuang, Hebei
Cuili Yang, +86 0311-66063051, yangcuil0821@163.com
- Not yet recruiting
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei
Erhei Dai, +86 0311-85925690, daieh2008@126.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Mingqin Lu, +86 0577-55579633, lmq0906@163.com
About this study
Official title: A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads
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.
Read the detailed description
see summary
- Conditions
- Hepatitis B
- Being tested
- TAF group, TDF group
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAF groupDrug
Also called TAF
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.
TDF groupDrug
Also called TDF
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.
| Study group | Role | What they receive |
|---|---|---|
| TAF group | Experimental | 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. Receives: Drug: TAF group |
| TDF group | Active comparator | 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. Receives: Drug: TDF group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start3 May 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou 8th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calvin Q.Pan, Guangzhou 8th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06947356
- Sponsor's protocol ID
- US-CN-P818
- Status last verified
- May 2025
- First submitted
- 20 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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: 1. 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. 2. 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. 3. Availability of the Data: The feasibility of sharing the requested data, considering any technical, legal, or logistical constraints, will be assessed. 4. Intended Use of the Data: The intended use of the data will be scrutinized to ensure it is appropriate
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Open-label, Non-inferiority Randomized Controlled Study on the Efficacy of Tenofovir Alafenamide Fumarate vs. Tenofovir Disoproxil Fumarate in Preventing Mother-to-Child Transmission of Hepatitis B Virus in Pregnant Women With High Viral Loads
- ClinicalTrials.gov ID
- NCT06947356
- Acronym / sponsor ID
- US-CN-P818
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Guangzhou 8th People's HospitalUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 27 Apr 2025 (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.
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.
Detailed description
see summary
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF group | Experimental | Drug: TAF groupPregnant 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. |
| TDF group | Active comparator | Drug: TDF groupThe 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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 < 80 g/L, neutrophil count < 1000/μL, ALT > 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.
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 |
|---|---|---|
| TAF groupAlso: TAFPregnant 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. | Drug | TAF group |
| TDF groupAlso: TDFThe 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. | Drug | TDF group |
Primary outcome
The mother-to-child transmission rate of HBV
Time frame: 28 weeks
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.
10 secondary outcomes
Congenital defects/malformations in infants
Time frame: 28 weeks
The percentage of mothers in each group of pregnant women with HBV DNA below 200,000 IU/mL
Time frame: 12 weeks
The percentage of mothers who experienced HBeAg/HBsAg clearance or seroconversion
Time frame: 36 weeks
ALT levels during or after TDF/TAF treatment
Time frame: 36 weeks
Renal function parameters of pregnant women
Time frame: 36 weeks
Adverse events (including obstetric complications and laboratory abnormalities)
Time frame: 36 weeks
Proportion of two groups that discontinued treatment due to adverse events
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time frame: 36 weeks
Health-related quality of life (HRQoL) indicators of pregnant women
Time frame: 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: 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: 1. 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. 2. 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. 3. Availability of the Data: The feasibility of sharing the requested data, considering any technical, legal, or logistical constraints, will be assessed. 4. Intended Use of the Data: The intended use of the data will be scrutinized to ensure it is appropriate
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAF group and TDF group in people with Hepatitis B, run by Guangzhou 8th People's Hospital at 10 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Calvin.Q Pan (+86 13632293277, Panc01@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mother-to-child transmission rate of HBV (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2025.