Chronic Hepatitis bNCT05466071
Safety and Efficacy of TAF to Prevent MTCT of HBV in Middle/Late Pregnancies With High HBV DNA Load
An observational study of Chronic Hepatitis b and Pregnancy Related, run by Xingfei Pan at 1 site in China.
Trial summary
Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Some infants born of mothers with high HBV DNA load (≥2×10^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Chronic Hepatitis b, Pregnancy Related
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 31 Dec 2026
- Phase
- Observational
- 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
Study population: We enroll Child-bearing age women with chronic HBV infection, who already become middle/late pregnancy, and visit in 3 hospitals (The Third Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangzhou Huadu District and He Xian Memorial Hospital of Guangzhou Panyu District).
Who may be able to join
- Age of 20-40 years.
- Positive for HBsAg ≥6 months.
- HBV DNA load of ≥ 2×10^5 IU/ml.
- Gestation 24-28 weeks .
- Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation.
- The good compliance of patients.
Who cannot join
- Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
- Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
- Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
- Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
- Clinical signs of threatened miscarriage.
- History of complication of pregnancy.
- History of nucleoside analogues (NA) treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital, Guangzhou Medical University
Guangzhou, Guangdong, 510150
Xingfei Pan, Doctor, +86 20 81292826, panxing0125@163.com
About this study
Official title: Safety and Efficacy of Tenofovir Alafenamide to Prevent Mother-to-child Transmission of Hepatitis B Virus in Middle/Late Pregnancies With High Hepatitis B Virus DNA Load: A Prospective Multicenter Cohort Study
Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Some infants born of mothers with high HBV DNA load (≥2×10^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Therefore, guidelines including AASLD and EASL recommend that pregnant women with high HBV DNA load should take antiviral drugs (tenofovir disoproxil fumarate or telbivudine) to reduce MTCT of HBV from gestation 24-28 weeks.
However, side effects of TDF on infants are reported. For example, neutropenia and the decrease of bone mineral density are found in early age infants who are ever exposed to TDF during their fetal life.
Read more
Tenofovir alafenamide (TAF), a new prodrug of tenofovir (TFV), has a higher antiviral potency, a higher peripheral blood mononuclear cell (PBMC) intracellular tenofovir diphosphate (TFV pp) level and a lower plasma TFV concentration. As the successor of TDF, the dose of TAF that is took orally every day is approximately 1/10 of TDF. TAF has a much lower risk of kidney toxicity and has almost no effect on the bone mineral density. TAF has been approved and recommended as the first-line drug to treat patients with chronic hepatitis B (CHB) by AASLD, EASL, etc. However, there are relatively few data of TAF on pregnancies with high HBV DNA load. It is urgently to clarify the safety and efficacy of TAF on interrupting MTCT of HBV in pregnancies with high HBV DNA load.
In the present study, the investigators enroll middle/late pregnancies with high HBV DNA load(≥2×10^5 IU/ml). The participants are randomly divided into two groups. Then the participants are treated with TAF or TDF respectively. All enrolled participants are followed-up for 2 years. Objectives of the present study are as follows:
- To clarify safety and efficacy of TAF on interrupting MTCT of HBV in middle/late pregnancies with high HBV DNA load.
- To clarify effects of TAF on obstetric complications in middle/late pregnancies with CHB.
- To clarify effects of TAF on birth defects of infants born in mothers with CHB.
- To clarify the change of virology and biochemistry indexes in women with CHB during pregnancy and postpartum.
- To clarify effects of TAF treatment on participants. F. To clarify growth parameters of the infants exposed to TAF during their fetal life.
- To clarify the pharmacokinetics of TAF in pregnant populations.
- Conditions
- Chronic Hepatitis b, Pregnancy Related
- Keywords
- Tenofovir Alafenamide, Safety and Efficacy, Mother-to-Child Transmission, High HBV DNA Load
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TAF group | Patients who take TAF during pregnancy. | |
| TDF group | Patients who take TDF during pregnancy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of interrupting MTCT
The proportion of HBV infection in the infants at 1 year of age.
Testing for HBsAg in the infants between 7 and 12 months of age.
Measured: During 7-12 months after birth
HBV DNA load in pregnancies
HBV DNA load is measured during 24-28 weeks of gestation and at birth, respectively.
Measured: After enrollment and up to delivery
ALT levels in pregnancies
ALT levels are measured every month during pregnancy.
Measured: After enrollment and up to delivery
HBeAg conversion rate in pregnancies
HBeAg is measured every 6 months during pregnancy.
Measured: After enrollment and up to delivery
Secondary outcomes (12)
Mode of delivery.
Recording the mode of delivery (vaginal delivery or cesarean delivery), and what kind of anesthesia (general anesthesia or combined spinal/epidural anesthesia) is used in the cesarean delivery.
Measured: At the time of delivery
The proportion of birth defects in the infants at 1 month age.
Measuring which kinds of congenital abnormality the infants have.
Measured: Up to 1 month after birth
Head circumferences of infants
Head circumferences of infants are measured and analyzed.
Measured: Once a year up to 3 years old after birth
Weights of infants
Weights of infants are measured and analyzed.
Measured: Once a year up to 3 years after birth
Heights of the infants
Heights of the infants are measured and analyzed.
Measured: Once a year up to 3 years after birth
Denver Developmental Screening Test of infants
Denver Developmental Screening Test of infants is measured and analyzed.
Measured: Once a year up to 3 years after birth
HBV DNA load in postpartum mothers
HBV DNA load is measured every 6 months postpartum.
Measured: Up to 2 years after delivery
ALT levels in postpartum mothers
ALT levels are measured every month during the first 3 months postpartum and every 6 months from the fourth month postpartum.
Measured: Up to 2 years after delivery
HBeAg conversion rate in postpartum mothers
HBeAg is measured every 6 months after delivery.
Measured: Up to 2 years after delivery
Liver function of women with CHB
Liver function is measured every 6 months postpartum.
Measured: Up to 2 years after delivery
Liver ultrasound test of women with CHB
Liver ultrasound is performed every 6 months postpartum.
Measured: Up to 2 years after delivery
The blood drug concentration of TAF in pregnancies
After the administration of TAF to pregnant women, 4 ml of upper extremity venous drug-containing blood is collected between 30 and 60 minutes before the next taking TAF at the 5th, 12th, 19th, 26th, 33rd, and 40th days, respectively. After a series of laboratory processes, the supernatant is taken for HPLC-MS/MS analysis, and the blood drug concentration at each time point is calculated according to the standard curve.
Measured: Day 5 up to day 40 after the administration of TAF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start1 Jun 2021
- Primary completion30 May 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingfei Pan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xingfei Pan, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466071
- Sponsor's protocol ID
- LCYJ-2021-005
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Tenofovir Alafenamide to Prevent Mother-to-child Transmission of Hepatitis B Virus in Middle/Late Pregnancies With High Hepatitis B Virus DNA Load: A Prospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05466071
- Acronym / sponsor ID
- LCYJ-2021-005
- Conditions
- Chronic Hepatitis b, Pregnancy Related
- Keywords
- Tenofovir Alafenamide, Safety and Efficacy, Mother-to-Child Transmission, High HBV DNA Load
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xingfei PanUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2022 (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.
Mother-to-child transmission (MTCT) is still the main transmission route of HBV in high-endemic areas, such as China, sub-Saharan Africa, etc. Some infants born of mothers with high HBV DNA load (≥2×10^5 IU/ml) are still infected with HBV even if these infants receive the combined immunization on time. Therefore, guidelines including AASLD and EASL recommend that pregnant women with high HBV DNA load should take antiviral drugs (tenofovir disoproxil fumarate or telbivudine) to reduce MTCT of HBV from gestation 24-28 weeks.
However, side effects of TDF on infants are reported. For example, neutropenia and the decrease of bone mineral density are found in early age infants who are ever exposed to TDF during their fetal life.
Tenofovir alafenamide (TAF), a new prodrug of tenofovir (TFV), has a higher antiviral potency, a higher peripheral blood mononuclear cell (PBMC) intracellular tenofovir diphosphate (TFV pp) level and a lower plasma TFV concentration. As the successor of TDF, the dose of TAF that is took orally every day is approximately 1/10 of TDF. TAF has a much lower risk of kidney toxicity and has almost no effect on the bone mineral density. TAF has been approved and recommended as the first-line drug to treat patients with chronic hepatitis B (CHB) by AASLD, EASL, etc. However, there are relatively few data of TAF on pregnancies with high HBV DNA load. It is urgently to clarify the safety and efficacy of TAF on interrupting MTCT of HBV in pregnancies with high HBV DNA load.
In the present study, the investigators enroll middle/late pregnancies with high HBV DNA load(≥2×10^5 IU/ml). The participants are randomly divided into two groups. Then the participants are treated with TAF or TDF respectively. All enrolled participants are followed-up for 2 years. Objectives of the present study are as follows:
- To clarify safety and efficacy of TAF on interrupting MTCT of HBV in middle/late pregnancies with high HBV DNA load.
- To clarify effects of TAF on obstetric complications in middle/late pregnancies with CHB.
- To clarify effects of TAF on birth defects of infants born in mothers with CHB.
- To clarify the change of virology and biochemistry indexes in women with CHB during pregnancy and postpartum.
- To clarify effects of TAF treatment on participants. F. To clarify growth parameters of the infants exposed to TAF during their fetal life.
- To clarify the pharmacokinetics of TAF in pregnant populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF group | – | –Patients who take TAF during pregnancy. |
| TDF group | – | –Patients who take TDF during pregnancy. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We enroll Child-bearing age women with chronic HBV infection, who already become middle/late pregnancy, and visit in 3 hospitals (The Third Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangzhou Huadu District and He Xian Memorial Hospital of Guangzhou Panyu District).
Key inclusion criteria (6 listed)
- Age of 20-40 years.
- Positive for HBsAg ≥6 months.
- HBV DNA load of ≥ 2×10^5 IU/ml.
- Gestation 24-28 weeks .
- Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation.
Key exclusion criteria (7 listed)
- Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease.
- Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity.
- Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators.
- Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality.
- Clinical signs of threatened miscarriage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of interrupting MTCT
Time frame: During 7-12 months after birth
The proportion of HBV infection in the infants at 1 year of age. Testing for HBsAg in the infants between 7 and 12 months of age.
HBV DNA load in pregnancies
Time frame: After enrollment and up to delivery
HBV DNA load is measured during 24-28 weeks of gestation and at birth, respectively.
ALT levels in pregnancies
Time frame: After enrollment and up to delivery
ALT levels are measured every month during pregnancy.
HBeAg conversion rate in pregnancies
Time frame: After enrollment and up to delivery
HBeAg is measured every 6 months during pregnancy.
12 secondary outcomes
Mode of delivery.
Time frame: At the time of delivery
The proportion of birth defects in the infants at 1 month age.
Time frame: Up to 1 month after birth
Head circumferences of infants
Time frame: Once a year up to 3 years old after birth
Weights of infants
Time frame: Once a year up to 3 years after birth
Heights of the infants
Time frame: Once a year up to 3 years after birth
Denver Developmental Screening Test of infants
Time frame: Once a year up to 3 years after birth
HBV DNA load in postpartum mothers
Time frame: Up to 2 years after delivery
ALT levels in postpartum mothers
Time frame: Up to 2 years after delivery
HBeAg conversion rate in postpartum mothers
Time frame: Up to 2 years after delivery
Liver function of women with CHB
Time frame: Up to 2 years after delivery
Liver ultrasound test of women with CHB
Time frame: Up to 2 years after delivery
The blood drug concentration of TAF in pregnancies
Time frame: Day 5 up to day 40 after the administration of TAF
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 31 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis b and Pregnancy Related, run by Xingfei Pan at 1 site 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 6 inclusion and 7 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Bing Situ, Master (+86 20 81292050, lilyst@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of interrupting MTCT (time frame: During 7-12 months after birth). The study lists 4 primary outcomes in all. 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 31 Aug 2026.