Chronic Hepatitis BPhase 4TAF-PPTNCT04850950
Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B
A Phase 4 study testing Tenofovir Alafenamide fumarate 25mg Oral Tablet in people with Chronic Hepatitis B and Mother-to-Child Transmission, run by The First Affiliated Hospital of Zhengzhou University.
Trial summary
To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Hepatitis B, Mother-to-Child Transmission, Safety
- What is being tested?
- Tenofovir Alafenamide fumarate 25mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2021to 31 Dec 2022
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age of more than 30 weeks;
- Had chronic hepatitis B virus (HBV) infection;
- HBV DNA > 200,000 IU/ml;
- Consecutively normal levels of alanine aminotransferase (< 40 U/L) and total bilirubin (< 17.1 μmol/L);
- Willing and able to provide written informed consent and adhere to the trial protocol.
Who cannot join
- Previous treatment to reduce alanine aminotransferase and total bilirubin levels;
- Previous antiviral treatment for HBV infection (except when antiviral agents were administered for the prevention of perinatal transmission during a previous pregnancy and discontinued more than 6 months before the current pregnancy);
- Coinfection with hepatitis C, D, E, or human immunodeficiency virus;
- Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;
- A hemoglobin level of less than 80 g/L;
- A neutrophil count of less than 1.0 × 10^9/L;
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- An albumin level of less than 30 g/L;
- Clinical signs of threatened miscarriage;
- Evidence of fetal deformity by ultrasound examination and other tests;
- A history of abortion, pregnancy loss, or congenital malformation in a previous pregnancy;
- A history of genetic disease(s), including the family member(s);
- Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, nonsteroidal antiinflammatory drugs, or steroids.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial
To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.
Read the detailed description
The investigators intend to include 240 inactive chronic hepatitis B virus (HBV)-infected pregnant women who have an HBV DNA level higher than 200,000 IU per milliliter. Participants will be randomly assigned, in a 1:1 ratio, to receive tenofovir alafenamide (orally 25 mg per day) from the late pregnancy until the delivery date or postpartum 1 month. All the infants will receive standard immunoprophylaxis (100 IU of hepatitis B immunoglobulin and 10 μg of hepatitis B vaccine within 12 hours of birth; the second injection of 10 μg of HBV vaccine will inject at 1 month; and the third dose of 10 μg of HBV vaccine will give at 6 months). The pregnant women and their infants will be followed until postpartum month 7. The primary outcomes are the birth defects and rates of perinatal transmission of HBV. During the prenatal period or the postnatal period up to 7 months of age, cases of a structural defect in newborns or infants were reported as birth defects. The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age. The secondary safety outcomes are the occurrence of maternal or infant adverse events during the study period. Maternal safety evaluations mainly include any adverse events and complications, hepatitis B virologic breakthrough, alanine aminotransferase flare, and so on. Infant' safety profiles mainly included Apgar scores at 1 minute, any abnormal conditions during the study period, and anthropometric indexes at birth and 7 months of age. The secondary efficacy outcomes are the percentages of mothers with an HBV DNA level of less than 200,000 IU per milliliter just before or at delivery, and the hepatitis B e antigen and surface antigen loss or seroconversion in mothers at postpartum month 7.
- Conditions
- Chronic Hepatitis B, Mother-to-Child Transmission, Safety, Efficacy, Hepatitis B Virus, Tenofovir Alafenamide Fumarate
- Being tested
- Tenofovir Alafenamide fumarate 25mg Oral Tablet
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide fumarate 25mg Oral TabletDrug
Also called VEMLIDY®
Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Tenofovir alafenamide fumarate discontinued at delivery date. Receives: Drug: Tenofovir Alafenamide fumarate 25mg Oral Tablet |
| Arm 2 | Experimental | Tenofovir alafenamide fumarate discontinued at postpartum month 1. Receives: Drug: Tenofovir Alafenamide fumarate 25mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth defects.
Structural defect in newborns or infants were reported as birth defects. The monitoring of birth defects was conducted by a clinical examination during each visit, and further clinical imaging or other tests were performed if indicated. The birth defect rate represented the proportion of infants with a defect among all live births.
Measured: From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age.
The rate of perinatal transmission of hepatitis B virus.
The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age.
Measured: At 7 months of age.
Secondary outcomes (6)
Adverse events.
The occurrence of any maternal or infant adverse events.
Measured: From prenatal tenofovir alafenamide exposure to the delivery (birth) and postnatal period up to 7 months (of age).
Alanine aminotransferase flare.
Alanine aminotransferase flare was defined as a level greater than 5 or 10 times the upper limit of normal, which was set as 40 U/L according to the Asian-Pacific chronic hepatitis B guideline.
Measured: At postpartum month 7.
Infants' growth.
Infant growth was measured by the WHO z scores for age for weight, height, and head circumference.
Measured: At birth and 7 months of age.
HBV DNA level.
Percentage of HBV DNA level of less than 200,000 IU per milliliter for mothers.
Measured: Immediately before or at delivery.
Hepatitis B e antigen status.
Percentage of hepatitis B e antigen loss or seroconversion for mothers.
Measured: At postpartum month 7.
Hepatitis B surface antigen status.
Percentage of hepatitis B surface antigen loss or seroconversion for mothers.
Measured: At postpartum month 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start26 Apr 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe sponsor's other registered studies.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Henan Provincial People's Hospital, The Sixth People's Hospital of Zhengzhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital, Luoyang Central Hospital, First Affiliated Hospital of Nanyang Medical College, Sixth People's Hospital of Kaifeng, Luohe Central Hospital, Xinyang Central Hospital, Yan'an University Affiliated Hospital, Nanyang Central Hospital, Fifth People's Hospital of Anyang
- Responsible party
- Principal investigator, Qing-Lei Zeng, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Qing-Lei Zeng, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850950
- Sponsor's protocol ID
- 2021-KY-0144-002
- Acronym
- TAF-PPT
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng QL, Zhou YH, Dong XP, Zhang JY, Li GM, Xu JH, Chen ZM, Song N, Zhang HX, Chen RY, Lv XY, Huang S, Li WZ, Pan YJ, Feng YH, Li ZQ, Zhang GF, Lin WB, Zhang GQ, Li GT, Li W, Zeng YL, Zhang DW, Cui GL, Lv J, Liu YM, Liang HX, Sun CY, Wang FS, Yu ZJ. Expected 8-Week Prenatal vs 12-Week Perinatal Tenofovir Alafenamide Prophylaxis to Prevent Mother-to-Child Transmission of Hepatitis B Virus: A Multicenter, Prospective, Open-Label, Randomized Controlled Trial. Am J Gastroenterol. 2025 May 1;120(5):1045-1056. doi: 10.14309/ajg.0000000000003122. Epub 2024 Oct 9.
PubMed 39382852
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tenofovir Alafenamide to Prevent Perinatal Transmission of Hepatitis B (TAF-PPT): A Multicentre, Prospective, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04850950
- Acronym / sponsor ID
- TAF-PPT / 2021-KY-0144-002
- Conditions
- Chronic Hepatitis B, Mother-to-Child Transmission, Safety, Efficacy, Hepatitis B Virus, Tenofovir Alafenamide Fumarate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Henan Provincial People's Hospital, The Sixth People's Hospital of Zhengzhou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Second Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital, Luoyang Central Hospital, First Affiliated Hospital of Nanyang Medical College, Sixth People's Hospital of Kaifeng, Luohe Central Hospital, Xinyang Central Hospital, Yan'an University Affiliated Hospital, Nanyang Central Hospital, Fifth People's Hospital of Anyang
- Study start
- 26 Apr 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Apr 2021 (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.
To investigate the safety and efficacy of tenofovir alafenamide (orally 25 mg per day) treated in inactive chronic hepatitis B virus (HBV)-infected pregnant women with high viral load from the late pregnancy until the delivery date or postpartum 1 month.
Detailed description
The investigators intend to include 240 inactive chronic hepatitis B virus (HBV)-infected pregnant women who have an HBV DNA level higher than 200,000 IU per milliliter. Participants will be randomly assigned, in a 1:1 ratio, to receive tenofovir alafenamide (orally 25 mg per day) from the late pregnancy until the delivery date or postpartum 1 month. All the infants will receive standard immunoprophylaxis (100 IU of hepatitis B immunoglobulin and 10 μg of hepatitis B vaccine within 12 hours of birth; the second injection of 10 μg of HBV vaccine will inject at 1 month; and the third dose of 10 μg of HBV vaccine will give at 6 months). The pregnant women and their infants will be followed until postpartum month 7. The primary outcomes are the birth defects and rates of perinatal transmission of HBV. During the prenatal period or the postnatal period up to 7 months of age, cases of a structural defect in newborns or infants were reported as birth defects. The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age. The secondary safety outcomes are the occurrence of maternal or infant adverse events during the study period. Maternal safety evaluations mainly include any adverse events and complications, hepatitis B virologic breakthrough, alanine aminotransferase flare, and so on. Infant' safety profiles mainly included Apgar scores at 1 minute, any abnormal conditions during the study period, and anthropometric indexes at birth and 7 months of age. The secondary efficacy outcomes are the percentages of mothers with an HBV DNA level of less than 200,000 IU per milliliter just before or at delivery, and the hepatitis B e antigen and surface antigen loss or seroconversion in mothers at postpartum month 7.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tenofovir Alafenamide fumarate 25mg Oral TabletTenofovir alafenamide fumarate discontinued at delivery date. |
| Arm 2 | Experimental | Drug: Tenofovir Alafenamide fumarate 25mg Oral TabletTenofovir alafenamide fumarate discontinued at postpartum month 1. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Gestational age of more than 30 weeks;
- Had chronic hepatitis B virus (HBV) infection;
- HBV DNA > 200,000 IU/ml;
- Consecutively normal levels of alanine aminotransferase (< 40 U/L) and total bilirubin (< 17.1 μmol/L);
- Willing and able to provide written informed consent and adhere to the trial protocol.
Key exclusion criteria (12 listed)
- Previous treatment to reduce alanine aminotransferase and total bilirubin levels;
- Previous antiviral treatment for HBV infection (except when antiviral agents were administered for the prevention of perinatal transmission during a previous pregnancy and discontinued more than 6 months before the current pregnancy);
- Coinfection with hepatitis C, D, E, or human immunodeficiency virus;
- Previous or current evidence of hepatocellular carcinoma, cirrhosis, systemic or other organ disorders;
- A hemoglobin level of less than 80 g/L;
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 Alafenamide fumarate 25mg Oral TabletAlso: VEMLIDY®Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1. | Drug | Arm 1, Arm 2 |
Primary outcome
Birth defects.
Time frame: From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age.
Structural defect in newborns or infants were reported as birth defects. The monitoring of birth defects was conducted by a clinical examination during each visit, and further clinical imaging or other tests were performed if indicated. The birth defect rate represented the proportion of infants with a defect among all live births.
The rate of perinatal transmission of hepatitis B virus.
Time frame: At 7 months of age.
The rate of perinatal transmission was defined as the proportion of infants who are positive for hepatitis B surface antigen at 7 months of age.
6 secondary outcomes
Adverse events.
Time frame: From prenatal tenofovir alafenamide exposure to the delivery (birth) and postnatal period up to 7 months (of age).
Alanine aminotransferase flare.
Time frame: At postpartum month 7.
Infants' growth.
Time frame: At birth and 7 months of age.
HBV DNA level.
Time frame: Immediately before or at delivery.
Hepatitis B e antigen status.
Time frame: At postpartum month 7.
Hepatitis B surface antigen status.
Time frame: At postpartum month 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Derived from this study: PubMed 39382852Zeng QL, Zhou YH, Dong XP, Zhang JY, Li GM, Xu JH, Chen ZM, Song N, Zhang HX, Chen RY, Lv XY, Huang S, Li WZ, Pan YJ, Feng YH, Li ZQ, Zhang GF, Lin WB, Zhang GQ, Li GT, Li W, Zeng YL, Zhang DW, Cui GL, Lv J, Liu YM, Liang HX, Sun CY, Wang FS, Yu ZJ. Expected 8-Week Prenatal vs 12-Week Perinatal Tenofovir Alafenamide Prophylaxis to Prevent Mother-to-Child Transmission of Hepatitis B Virus: A Multicenter, Prospective, Open-Label, Randomized Controlled Trial. Am J Gastroenterol. 2025 May 1;120(5):1045-1056. doi: 10.14309/ajg.0000000000003122. Epub 2024 Oct 9.
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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.
Qing-Lei Zeng principal investigator
The First Affiliated Hospital of Zhengzhou University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir Alafenamide fumarate 25mg Oral Tablet in people with Chronic Hepatitis B and Mother-to-Child Transmission, run by The First Affiliated Hospital of Zhengzhou University.
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 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Qing-Lei Zeng, M.D. (86 15838120512, zengqinglei2009@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth defects. (time frame: From prenatal tenofovir alafenamide exposure to the birth and postnatal period up to 7 months of age.). The study lists 2 primary outcomes in all. 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 NCT04850950, which also lists 1 linked publication.
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 23 Apr 2021.