HBVPhase 4NCT05063071
Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant
A Phase 4 study testing Tenofovir Alafenamide 25 MG in people with HBV and POST LIVER TRANSPLANT, run by Fudan University at 1 site in China.
Trial summary
TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HBV, POST LIVER TRANSPLANT
- What is being tested?
- Tenofovir Alafenamide 25 MG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2021to 29 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.
- ≥18 years old.
- Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.
- HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)
Who cannot join
- Post OLT patients received HBIG
- Other solid organs transplant recipients
- HCV, HDV or HIV coinfection
- Other primary end-stage liver diseases (PBC, PSC, etc)
- Patients with underwent liver re-transplantation
- Liver grafts from HBsAg+ donors
- Graft dysfunction of any other causes
- HCC with primary portal vein thrombus
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease
TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.
Read the detailed description
LT has evolved rapidly, becoming the standard therapy for acute and chronic liver failure of a variety of aetiologies, with more than 80,000 procedures performed to date [13]. HBV infection is a worldwide public health problem, especially in China. The need for an antiviral treatment with NAs for liver transplant recipients has two objectives: the improvement of liver function and to decrease the risk of HBV recurrence after transplant. TAF, TDF and ETV are currently the first-line therapy in patients with CHB in all CHB treatment guidelines, which have a greater potency and higher barriers to resistance. TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.
- Conditions
- HBV, POST LIVER TRANSPLANT
- Being tested
- Tenofovir Alafenamide 25 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Alafenamide 25 MGDrug
After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.
| Study group | Role | What they receive |
|---|---|---|
| TAF monotherapy without HBIG | Experimental | The standard dose of TAF 25mg daily was used. TAF can be used on the first day after orthotopic liver transplantation. No HBIG was used before, during, or after transplantation; and therapeutic vaccination was not routinely used. Receives: Drug: Tenofovir Alafenamide 25 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA undetectable rate at week 48.
evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 48 after liver transplant.
Measured: 48 weeks
Secondary outcomes (11)
HBV DNA undetectable rate at week 96
evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 96 after liver transplant.
Measured: 96 weeks
HBsAg negative rate at week 48
evaluate the HBsAg negative rate at week 48 after liver transplant.
Measured: 48 weeks
HBsAg negative rate at week 96
evaluate the HBsAg negative rate at week 96 after liver transplant.
Measured: 96 weeks
ALT normalization rate at week 48
evaluate the ALT normalization rate at week 48 after liver transplant.
Measured: 48 weeks
ALT normalization rate at week 96
evaluate the ALT normalization rate at week 96 after liver transplant.
Measured: 96 weeks
Changes in Serum Creatinine at week 48
evaluate the change of Serum Creatinine at week 48 after liver transplant.
Measured: 48 weeks
Changes in Serum Creatinine at week 96
evaluate the change of Serum Creatinine at week 96 after liver transplant.
Measured: 96 weeks
Changes in eGFR (MDRD) at week 48
evaluate the change of eGFR (MDRD) at week 48 after liver transplant.
Measured: 48 weeks
Changes in eGFR (MDRD) at week 96
evaluate the change of eGFR (MDRD) at week 96 after liver transplant.
Measured: 96 weeks
Changes in β2-MG:Cr at week 48
evaluate the change of β2-MG:Cr at week 48 after liver transplant.
Measured: 48 weeks
Changes in β2-MG:Cr at week 96
evaluate the change of β2-MG:Cr at week 96 after liver transplant.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start29 Jul 2021
- Primary completion29 Jul 2022 (estimated)
- Study completion29 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhou, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063071
- Sponsor's protocol ID
- TAF-Prophylaxis-Post Liver Tx
- Status last verified
- Jul 2021
- First submitted
- 18 Aug 2021
- Last updated
- 30 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Tenofovir Alafenamide for HBV Prophylaxis in Post Orthotopic Liver Transplant With HBV-related Disease
- ClinicalTrials.gov ID
- NCT05063071
- Acronym / sponsor ID
- TAF-Prophylaxis-Post Liver Tx
- Conditions
- HBV, POST LIVER TRANSPLANT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 29 Jul 2022 (estimated)
- Study completion
- 29 Dec 2022 (estimated)
- First posted
- 30 Sep 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.
TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.
Detailed description
LT has evolved rapidly, becoming the standard therapy for acute and chronic liver failure of a variety of aetiologies, with more than 80,000 procedures performed to date [13]. HBV infection is a worldwide public health problem, especially in China. The need for an antiviral treatment with NAs for liver transplant recipients has two objectives: the improvement of liver function and to decrease the risk of HBV recurrence after transplant. TAF, TDF and ETV are currently the first-line therapy in patients with CHB in all CHB treatment guidelines, which have a greater potency and higher barriers to resistance. TAF treatment for HBV prophylaxis could lead to significant reduction in ALT and significant improvement in renal function. However, data are scarce regarding to TAF monotherapy without HBIG for HBV prophylaxis in post orthotopic liver transplant with HBV-related disease. This study is based on a real-world, multi-center, prospective study to assess the effectiveness and safety of TAF for HBV prophylaxis, which will fill in gaps with TAF monotherapy without HBIG in post liver transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAF monotherapy without HBIG | Experimental | Drug: Tenofovir Alafenamide 25 MGThe standard dose of TAF 25mg daily was used. TAF can be used on the first day after orthotopic liver transplantation. No HBIG was used before, during, or after transplantation; and therapeutic vaccination was not routinely used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must be capable of understanding and signing written informed consent; Before commencing the study procedure, participants must obtain informed consent. If the patient is hepatic Coma, the family member shall sign the written informed consent.
- ≥18 years old.
- Orthotopic liver transplant for HBV-related disease (such as HCC, DCC or liver failure). Patients were all positive for HBsAg for at least 6 months prior to liver transplantation.
- HBV DNA ≤ 2000 IU/mL before orthotopic liver transplant . (Including patients who received or did not receive oral antiviral therapy before liver transplantation)
Key exclusion criteria (8 listed)
- Post OLT patients received HBIG
- Other solid organs transplant recipients
- HCV, HDV or HIV coinfection
- Other primary end-stage liver diseases (PBC, PSC, etc)
- Patients with underwent liver re-transplantation
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 25 MGAfter orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis. | Drug | TAF monotherapy without HBIG |
Primary outcome
HBV DNA undetectable rate at week 48.
Time frame: 48 weeks
evaluate the HBV DNA undetectable rate (defined as HBV DNA < 20 IU/mL) at week 48 after liver transplant.
11 secondary outcomes
HBV DNA undetectable rate at week 96
Time frame: 96 weeks
HBsAg negative rate at week 48
Time frame: 48 weeks
HBsAg negative rate at week 96
Time frame: 96 weeks
ALT normalization rate at week 48
Time frame: 48 weeks
ALT normalization rate at week 96
Time frame: 96 weeks
Changes in Serum Creatinine at week 48
Time frame: 48 weeks
Changes in Serum Creatinine at week 96
Time frame: 96 weeks
Changes in eGFR (MDRD) at week 48
Time frame: 48 weeks
Changes in eGFR (MDRD) at week 96
Time frame: 96 weeks
Changes in β2-MG:Cr at week 48
Time frame: 48 weeks
Changes in β2-MG:Cr at week 96
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Jian Zhou principal investigator
Shanghai Zhongshan Hospital
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 Tenofovir Alafenamide 25 MG in people with HBV and POST LIVER TRANSPLANT, run by Fudan 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 4 inclusion and 8 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 30 Sep 2021. 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?
Results are not available in the source record.
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?
HBV DNA undetectable rate at week 48. (time frame: 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 30 Sep 2021.