Hepatitis B InfectionPhase 4TAF;CHBNCT07668934
TAF in Early/Middle Pregnancy With CHB
A Phase 4 study testing TAF and TDF in people with Hepatitis B Infection and Pregnant Women, run by The Third Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Hepatitis B Infection, Pregnant Women, Early Pregnancy
- What is being tested?
- TAF and TDF
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2025to 30 Mar 2028
- Phase
- Phase 4
- 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
- Between the ages of 20 and 40
- HBsAg positive for >= 6 months
- 0-24 week of pregnancy
- Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B
- It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution
- Signed informed consent for medication
Who cannot join
- Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.)
- Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS
- Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.)
- Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases
- Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
- Patients with previous pregnancy complications (such as: gestational hypertension, gestational diabetes, gestational eclampsia, etc.)
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- Those who have had fetal or neonatal growth and development defects in previous pregnancies
- Previous or ongoing use of nephrotoxic medications, glucocorticoids, nonsteroidal anti-inflammatory drugs, cytotoxic drugs, or immunomodulators
- Premedication ultrasound showed fetal malformations, fetal development abnormalities, placental abnormalities, threatened abortion, etc
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
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.
Read the detailed description
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.
- Conditions
- Hepatitis B Infection, Pregnant Women, Early Pregnancy
- Being tested
- TAF, TDF
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAFDrug
Also called tenofovir alafenamide
Taking TAF from early or middle pregnancy
TDFDrug
Also called tenofovir disoproxil fumarate
Taking TDF from early or middle pregnancy
| Study group | Role | What they receive |
|---|---|---|
| tenofovir alafenamide | Experimental | An oral drug for reducing hepatitis B virus levels. Receives: Drug: TAF |
| tenofovir disoproxil fumarate | Active comparator | An oral drug for reducing hepatitis B virus levels. Receives: Drug: TDF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the incidence of ALT above normal (>=1 time) of mother
From the time of initiation of antiviral and normal ALT until delivery
Measured: not more than 48 weeks
Secondary outcomes (13)
To assess the level of HBV-DNA of baby
At birth; At 7 months of age
Measured: not more than 7 months
To assess the level of HBV-DNA of mother
Every 4 weeks of pregnancy
Measured: not more than 48 weeks
To assess the results of liver Ultrasound of mother
At the time of enrollment; During childbirth
Measured: not more than 48 weeks
To assess the weight in kilograms of baby
At birth; At 7 months of age
Measured: not more than 7 months
To assess the height in meters of baby
At birth; At 7 months of age
Measured: not more than 7 months
The number of HBsAg positive of baby
At birth; At 7 months of age
Measured: not more than 7 months
The number of HBeAg positive of baby
At birth; At 7 months of age
Measured: not more than 7 months
The number of HBsAg positive of mother
Every 4 weeks of pregnancy
Measured: not more than 48 weeks
The number of HBeAg positive of mother
Every 4 weeks of pregnancy
Measured: not more than 48 weeks
The rate of deformity
Fetal period
Measured: not more than 48 weeks
The rate of Birth defect
At birth
Measured: 1 day
The levels of creatinine of mother
From the time of initiation of antiviral until delivery
Measured: not more than 48 weeks
The levels of blood lipids of mother
From the time of initiation of antiviral until delivery
Measured: not more than 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start31 Mar 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 816 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital
- Responsible party
- Sponsor
- Investigators
- Panpan Zhai, Principal investigator, The Third Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668934
- Sponsor's protocol ID
- [2025]004
- Acronym
- TAF;CHB
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TAF Used in Early and Middle Pregnancy With Chronic Hepatitis B: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07668934
- Acronym / sponsor ID
- TAF;CHB / [2025]004
- Conditions
- Hepatitis B Infection, Pregnant Women, Early Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 816 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Guangzhou Medical University, Qingyuan People's Hospital
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 25 Jun 2026 (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 goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B.
Detailed description
The goal of this clinical trial is to study the efficacy and safety of Tenofovir alafenamide (TAF) vs Tenofovir disoproxil fumarate(TDF) in early and middle pregnancy with chronic hepatitis B. Previous studies have found that TAF has good clinical efficacy in the treatment of antiviral therapy in patients with chronic hepatitis B. In order to evaluate the clinical efficacy of TAF after antiviral therapy in pregnant women with chronic hepatitis B in the first and second trimesters, the clinical efficacy of TAF after antiviral therapy was evaluated by comparing the safety (including changes in maternal ALT, bilirubin, creatinine, blood phosphorus, blood lipids, fetal malformation rate, neonatal birth defects, head circumference, height, weight, intelligence and other indicators) and effectiveness (viral load decrease, serological conversion, mother-to-fetal blockade, etc.) with the TDF group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenofovir alafenamide | Experimental | Drug: TAFAn oral drug for reducing hepatitis B virus levels. |
| tenofovir disoproxil fumarate | Active comparator | Drug: TDFAn oral drug for reducing hepatitis B virus levels. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between the ages of 20 and 40
- HBsAg positive for >= 6 months
- 0-24 week of pregnancy
- Meets the indications for antiviral therapy in the 2022 version of the guidelines for the prevention and treatment of chronic hepatitis B
- It is planned to use TAF or TDF antiviral therapy until the end of delivery or long-term administration, and follow-up will be carried out in this research institution
Key exclusion criteria (9 listed)
- Previous use of anti-hepatitis B virus drugs (e.g., entecavir, tenofovir, tenofovir alafenol, emintenofovir, adefovir dipoproxil, telbivudine, etc.)
- Concomitant viral hepatitis A, C, E or other hepatotropic virus infection or AIDS
- Concomitant cirrhosis, liver cancer or other chronic liver diseases (e.g., alcoholic liver, autoimmune liver disease, G6PD deficiency, etc.)
- Patients with heart (such as coronary heart disease, myocardial infarction, heart failure, etc.), lung (such as: lung cancer, chronic obstructive pulmonary disease, tuberculosis, etc.), kidney (such as: renal failure, elevated creatinine, nephritis, nephrotic syndrome, etc.) and other important organ diseases
- Chronic diseases such as autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, anticoagulant antibody syndrome), hypertension, diabetes, thyroid disease, etc
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 |
|---|---|---|
| TAFAlso: tenofovir alafenamideTaking TAF from early or middle pregnancy | Drug | tenofovir alafenamide |
| TDFAlso: tenofovir disoproxil fumarateTaking TDF from early or middle pregnancy | Drug | tenofovir disoproxil fumarate |
Primary outcome
To assess the incidence of ALT above normal (>=1 time) of mother
Time frame: not more than 48 weeks
From the time of initiation of antiviral and normal ALT until delivery
13 secondary outcomes
To assess the level of HBV-DNA of baby
Time frame: not more than 7 months
To assess the level of HBV-DNA of mother
Time frame: not more than 48 weeks
To assess the results of liver Ultrasound of mother
Time frame: not more than 48 weeks
To assess the weight in kilograms of baby
Time frame: not more than 7 months
To assess the height in meters of baby
Time frame: not more than 7 months
The number of HBsAg positive of baby
Time frame: not more than 7 months
The number of HBeAg positive of baby
Time frame: not more than 7 months
The number of HBsAg positive of mother
Time frame: not more than 48 weeks
The number of HBeAg positive of mother
Time frame: not more than 48 weeks
The rate of deformity
Time frame: not more than 48 weeks
The rate of Birth defect
Time frame: 1 day
The levels of creatinine of mother
Time frame: not more than 48 weeks
The levels of blood lipids of mother
Time frame: not more than 48 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 25 Jun 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.
Panpan Zhai principal investigator
The Third Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAF and TDF in people with Hepatitis B Infection and Pregnant Women, run by The Third Affiliated Hospital of Guangzhou Medical University 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 9 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 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.
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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the incidence of ALT above normal (>=1 time) of mother (time frame: not more than 48 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 25 Jun 2026.