Acute-graft-versus-host DiseasePhase 3SHIELDNCT05149365
Sitagliptin for Prevention of aGVHD After Alternative Donor Transplation
A Phase 3 study testing Sitagliptin + Standard Prophylaxis and Standard Prophylaxis in people with Acute-graft-versus-host Disease and Allogeneic Hematopoietic Stem Cell Transplantation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Primary Objective: It is hypothesized that the efficacy of Sitagliptin would reduce the incidence of grade II-IV acute Graft Versus Host Disease (GVHD) by day +100 post-transplant in patients undergoing alternative donor (related haploid or unrelated donor ) allogeneic Hematopoietic Stem Cell Transplantation (HSCT)… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute-graft-versus-host Disease, Allogeneic Hematopoietic Stem Cell Transplantation
- What is being tested?
- Sitagliptin + Standard Prophylaxis and Standard Prophylaxis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 16 Jun 2025
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient age ≥ 18 to ≤ 60 years
- Eastern Cooperative Oncology Group (ECOG）score 0-2 points / Karnofsky score ≧80
- To receive allogeneic hematopoietic stem cell transplantation from related haploid or unrelated donor
- The pretreatment of modified Bu/Cy+ATG scheme was planned.
- Patients with malignant hematological diseases indicated by transplantation and in complete remission (CR) state.
- Expected survival ≥ 3 months
- Signed written informed consent (Patient must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent)
- Agree to use effective contraception
Who cannot join
- Prior allogeneic hematopoietic stem cell transplant
- Allergy/intolerance to Sitagliptin
- There are contraindications for Sitagliptin use.
- Moderate or severe renal insufficiency
- Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
- Human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection
Show all 12Show fewer
- Active infection that is difficult to control
- Vital organ function cannot tolerate transplantation
- Other malignant tumors outside the blood system, except the following diseases: malignant tumors that have been cured for 3 years without active lesions; Adequate treatment of non-melanoma skin cancer without active foci of malignant amygdala and carcinoma in situ
- There is evidence that may interfere with the study or make patients at risk of serious complications or medical conditions, including but not limited to serious cardiovascular diseases (such as New York heart association class III or IV heart disease over the past six months of myocardial infarction, unstable type of cardiac arrhythmias) or unstable angina and/or severe lung disease (e.g. History of severe obstructive pulmonary disease and symptomatic bronchospasm)
- Pregnant or lactating women
- Any life-threatening medical condition or organ system dysfunction considered by the investigator may endanger the patient's safety by interfering with the absorption or metabolism of sitagliptin or putting study results at unnecessary risk
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
Suzhou, Jiangsu, 215000
About this study
Official title: Sitagliptin Efficacy and Safety for Prevention of Acute Graft Versus Host Disease in Patients Receiving Alternative Donor Allogeneic Hematopoietic Stem Cell Transplantation
Primary Objective:
It is hypothesized that the efficacy of Sitagliptin would reduce the incidence of grade II-IV acute Graft Versus Host Disease (GVHD) by day +100 post-transplant in patients undergoing alternative donor (related haploid or unrelated donor ) allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and receiving standard GVHD prophylaxis.
Read more
Secondary Objectives
The following descriptive secondary objectives will be studied:
- Determine the tolerability and potential toxicity of sitagliptin in patients undergoing allogeneic HSCT.
- Determine the cumulative incidence of grades II-IV acute GVHD by day +100.
- To investigate the cumulative incidence of grades III-IV acute GVHD.
- To investigate the engraftment kinetics of absolute neutrophil count and platelets.
- To evaluate the incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and other infections occurring during the 100 days post-transplant.
- To study non-relapse mortality (NRM) at day +100, and 1 year post-transplant.
- Determine the overall survival at 1 year post-transplant.
- Determine the incidence of chronic GVHD.
- Determine the cumulative incidence of relapse of the primary hematological malignancy.
Read the detailed description
This is a Prospective, Multi-center, Open-label, Randomized, Controlled clinical trial of Sitagliptin for the prevention and safety of aGVHD after Alternative Donor hematopoietic stem cell transplantation.
190 adult patients with hematologic malignancies receiving haploid or unrelated donor sourced HSCT are planned to be enrolled competitively in this study from 5 clinical centers in China. These patients will be randomly assigned to two groups of 95 patients each, which one is experimental group and the other is control group. 95 patients in experimental group will receive Sitagliptin combined with Standard prophylaxis for GVHD. 95 patients in the control group will receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT.
Control group uses antithymocyte immunoglobulin (ATG)+cyclosporin A (CSA)+MMF+MTX for GVHD prophylaxis with the details as follows: CSA 3mg/kg continuous i.v. drip, start before Day -7, change to p.o. when gastrointestinal function recovers with a dose of 5mg/kg as two divided doses, maintaining CSA within 150-250ng/ml（If CsA cannot be tolerated, tacrolimus may be used as an alternative.）; MTX 15mg/m2,Day +1, 10mg/m2,Days +3, +6, and +11; MMF 0.5g bid, starting from Day -7 to day +30 for one month; ATG 2.5mg/kg/d, Day -4 to Day -1.
Experimental group will take Sitagliptin orally from d-1 to d+14 in addition to Standard Prophylaxis Regimen.
With regard to the content of dose reduction of CSA (including time and reduction rate), it is recommended for patients with hematologic malignancies in standard risk group to start to reduce dose after 3-6 months in the absence of GVHD and reoccurrence. The specific reduction rate can be determined at each site; the patients with GVHD will be managed by routine practice in this site.
- Being tested
- Sitagliptin + Standard Prophylaxis, Standard Prophylaxis
- Keywords
- Sitagliptin, Alternative Donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sitagliptin + Standard ProphylaxisDrug
Also called Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin
Sitagliptin 600 mg ever 12 hours orally will be given starting from the day before transplantation through day +14 after transplantation and Standard prophylaxis regimen
Standard ProphylaxisDrug
Also called Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin
Standard prophylaxis regimen for GVHD of Alternative Donor HSCT, include Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin Group | Experimental | 95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will receive Sitagliptin combined with Standard prophylaxis regimen for GVHD of Alternative Donor HSCT. Receives: Drug: Sitagliptin + Standard Prophylaxis |
| Standard Group | Active comparator | 95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will only receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT Receives: Drug: Standard Prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development Grade II-IV Acute GVHD by Day +100 Following Transplantation
Percent of patients and the 95% Confidence interval who have Grade II-IV Acute GVHD by 100 days following transplantation. Only patients who were on the study for at least 100 days post transplantation were included in the analysis.
Measured: up to 100 days
Secondary outcomes (10)
Development Grade II-IV Acute GVHD at Day +100
Fine-Gray and Cause-specific COX methods will be used to conduct a competing risk analysis. Time until grade II-IV acute GVHD will be calculated from transplant through grade II-IV acute GVHD or death from GVHD. Patients who relapsed or died from causes other than GVHD will be considered a competing risk population and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of grade II-IV acute GVHD at day +100 was calculated along with a 95% confidence interval.
Measured: 100 days from transplant
Percentage of Patients With Grade III-IV Acute GVHD at Day +100
Fine-Gray and Cause-specific COX methods will be used to conduct a competing risk analysis. Time until grade III-IV acute GVHD will be calculated from transplant until grade III-IV acute GVHD or death from GVHD. Patients who relapsed or died from causes other than GVHD will be considered a competing risk and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of grade II-IV acute GVHD at day +100 was calculated along with a 95% confidence interval.
Measured: 100 days from transplant
Cumulative incidence of early transplant-related death (TRM) within 100 days after transplantation
Percent of patients and the 95% Confidence interval who died within 100 days after transplantation.
Measured: 100 days from transplant
Median Time to Engraftment of Neutrophils
Time to neutrophil engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of neutrophils is defined as the time from day 0 to the date of the first of three consecutive days after transplantation during which the absolute neutrophils count (ANC) is at least 0.5 x109/l. Patients who did not have neutrophil engraftment before death will be censored at the date of death. The median and 95% confidence intervals were calculated.
Measured: up to 1 month
Median Time to Engraftment of Platelets
Time to platelet engraftment will be analyzed by the Kaplan-Meier method. The time to engraftment of platelets is defined as the time from day 0 to the first of seven consecutive Complete Blood Counts (CBCs) obtained on different days after transplantation during which the platelet count is at least 20 x109/l. The CBCs obtained should be at least seven days after the most recent platelet transfusion. The median and 95% confidence intervals were calculated.
Measured: up to 4 months
Number of Unique Patients With Infections by Day +100
Number of unique patients who had each type of infection (i.e., viral, bacterial, fungal, etc.) during the 100 days post transplant. A patient could have more than one type of infection.
Measured: 100 days from transplant
Percentage of Patients With Non-relapse Mortality (NRM) at +1 Year
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until non-relapse death will be calculated from transplant until death. Patients who died from relapse will be considered a competing risk and calculated from time of transplant until death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of non-relapse mortality at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients Surviving at +1 Year
Duration of time from the start of treatment to time of death due to any causes. Patients who do not die will be censored on their last known alive date. Kaplan-Meier methods will be used and the median and 95% confidence intervals will be calculated. The cumulative incidence percentage of survival at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients Diagnosed With Chronic GVHD at 1 Year
Patients surviving at least 100 days will be evaluable for chronic GVHD. The cumulative incidence of chronic GVHD (total, and mild, moderate, severe) will be described using deaths from causes other than chronic GVHD considered as a competing risk. Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until chronic GVHD will be calculated from transplant until chronic GVHD or death from GVHD. Patients who relapsed or died from causes other than GVHD will be considered a competing risk and calculated from time of transplant until relapse or death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage at 1 year will calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Percentage of Patients With Relapse of the Primary Hematological Malignancy at 1 Year
Kaplan-Meier methods will be used to conduct a competing risk analysis. Time until relapse will be calculated from transplant until relapse or death from relapse. Patients who died from causes other than relapse will be considered a competing risk and calculated from time of transplant until death. Otherwise, patients will be censored and calculated from transplant until the last known alive date. The cumulative incidence percentage of relapse at day +365 was calculated along with a 95% confidence interval.
Measured: 1 year from transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start22 Dec 2021
- Primary completion24 Sep 2023
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Multi-center, Open-label, Randomized, Controlled Clinical Trial
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Second People's Hospital of Huai'an, The First People's Hospital of Changzhou, Xinqiao Hospital of Chongqing, Shenzhen People's Hospital
- Responsible party
- Sponsor
- Investigators
- Suning Chen, Professor, Principal investigator, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149365
- Sponsor's protocol ID
- SZ-GVHD 06
- Acronym
- SHIELD
- Status last verified
- Jun 2025
- First submitted
- 25 Nov 2021
- Last updated
- 10 Feb 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 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin Efficacy and Safety for Prevention of Acute Graft Versus Host Disease in Patients Receiving Alternative Donor Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05149365
- Acronym / sponsor ID
- SHIELD / SZ-GVHD 06
- Keywords
- Sitagliptin, Alternative Donor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, The Second People's Hospital of Huai'an, The First People's Hospital of Changzhou, Xinqiao Hospital of Chongqing, Shenzhen People's Hospital
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 8 Dec 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.
Primary Objective:
It is hypothesized that the efficacy of Sitagliptin would reduce the incidence of grade II-IV acute Graft Versus Host Disease (GVHD) by day +100 post-transplant in patients undergoing alternative donor (related haploid or unrelated donor ) allogeneic Hematopoietic Stem Cell Transplantation (HSCT) and receiving standard GVHD prophylaxis.
Secondary Objectives
The following descriptive secondary objectives will be studied:
- Determine the tolerability and potential toxicity of sitagliptin in patients undergoing allogeneic HSCT.
- Determine the cumulative incidence of grades II-IV acute GVHD by day +100.
- To investigate the cumulative incidence of grades III-IV acute GVHD.
- To investigate the engraftment kinetics of absolute neutrophil count and platelets.
- To evaluate the incidence of Cytomegalovirus (CMV), Epstein-Barr virus (EBV) and other infections occurring during the 100 days post-transplant.
- To study non-relapse mortality (NRM) at day +100, and 1 year post-transplant.
- Determine the overall survival at 1 year post-transplant.
- Determine the incidence of chronic GVHD.
- Determine the cumulative incidence of relapse of the primary hematological malignancy.
Detailed description
This is a Prospective, Multi-center, Open-label, Randomized, Controlled clinical trial of Sitagliptin for the prevention and safety of aGVHD after Alternative Donor hematopoietic stem cell transplantation.
190 adult patients with hematologic malignancies receiving haploid or unrelated donor sourced HSCT are planned to be enrolled competitively in this study from 5 clinical centers in China. These patients will be randomly assigned to two groups of 95 patients each, which one is experimental group and the other is control group. 95 patients in experimental group will receive Sitagliptin combined with Standard prophylaxis for GVHD. 95 patients in the control group will receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT.
Control group uses antithymocyte immunoglobulin (ATG)+cyclosporin A (CSA)+MMF+MTX for GVHD prophylaxis with the details as follows: CSA 3mg/kg continuous i.v. drip, start before Day -7, change to p.o. when gastrointestinal function recovers with a dose of 5mg/kg as two divided doses, maintaining CSA within 150-250ng/ml（If CsA cannot be tolerated, tacrolimus may be used as an alternative.）; MTX 15mg/m2,Day +1, 10mg/m2,Days +3, +6, and +11; MMF 0.5g bid, starting from Day -7 to day +30 for one month; ATG 2.5mg/kg/d, Day -4 to Day -1.
Experimental group will take Sitagliptin orally from d-1 to d+14 in addition to Standard Prophylaxis Regimen.
With regard to the content of dose reduction of CSA (including time and reduction rate), it is recommended for patients with hematologic malignancies in standard risk group to start to reduce dose after 3-6 months in the absence of GVHD and reoccurrence. The specific reduction rate can be determined at each site; the patients with GVHD will be managed by routine practice in this site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Multi-center, Open-label, Randomized, Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin Group | Experimental | Drug: Sitagliptin + Standard Prophylaxis95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will receive Sitagliptin combined with Standard prophylaxis regimen for GVHD of Alternative Donor HSCT. |
| Standard Group | Active comparator | Drug: Standard Prophylaxis95 adult patients with hematologic malignancies receiving Alternative Donor HSCT, who will only receive Standard prophylaxis regimen for GVHD of Alternative Donor HSCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patient age ≥ 18 to ≤ 60 years
- Eastern Cooperative Oncology Group (ECOG）score 0-2 points / Karnofsky score ≧80
- To receive allogeneic hematopoietic stem cell transplantation from related haploid or unrelated donor
- The pretreatment of modified Bu/Cy+ATG scheme was planned.
- Patients with malignant hematological diseases indicated by transplantation and in complete remission (CR) state.
Key exclusion criteria (12 listed)
- Prior allogeneic hematopoietic stem cell transplant
- Allergy/intolerance to Sitagliptin
- There are contraindications for Sitagliptin use.
- Moderate or severe renal insufficiency
- Patients with diabetes mellitus requiring insulin secretagogues and/or insulin
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 |
|---|---|---|
| Sitagliptin + Standard ProphylaxisAlso: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic GlobulinSitagliptin 600 mg ever 12 hours orally will be given starting from the day before transplantation through day +14 after transplantation and Standard prophylaxis regimen | Drug | Sitagliptin Group |
| Standard ProphylaxisAlso: Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic GlobulinStandard prophylaxis regimen for GVHD of Alternative Donor HSCT, include Cyclosporine (CsA),Methotrexate (MTX), Mycopherol ester (MMF) and Antithymic Globulin | Drug | Standard Group |
Primary outcome
Development Grade II-IV Acute GVHD by Day +100 Following Transplantation
Time frame: up to 100 days
Percent of patients and the 95% Confidence interval who have Grade II-IV Acute GVHD by 100 days following transplantation. Only patients who were on the study for at least 100 days post transplantation were included in the analysis.
10 secondary outcomes
Development Grade II-IV Acute GVHD at Day +100
Time frame: 100 days from transplant
Percentage of Patients With Grade III-IV Acute GVHD at Day +100
Time frame: 100 days from transplant
Cumulative incidence of early transplant-related death (TRM) within 100 days after transplantation
Time frame: 100 days from transplant
Median Time to Engraftment of Neutrophils
Time frame: up to 1 month
Median Time to Engraftment of Platelets
Time frame: up to 4 months
Number of Unique Patients With Infections by Day +100
Time frame: 100 days from transplant
Percentage of Patients With Non-relapse Mortality (NRM) at +1 Year
Time frame: 1 year from transplant
Percentage of Patients Surviving at +1 Year
Time frame: 1 year from transplant
Percentage of Patients Diagnosed With Chronic GVHD at 1 Year
Time frame: 1 year from transplant
Percentage of Patients With Relapse of the Primary Hematological Malignancy at 1 Year
Time frame: 1 year from transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 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. This study is not recruiting at the moment.
Suning Chen, Professor principal investigator
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin + Standard Prophylaxis and Standard Prophylaxis in people with Acute-graft-versus-host Disease and Allogeneic Hematopoietic Stem Cell Transplantation, run by The First Affiliated Hospital of Soochow 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 8 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: finished, as of the sponsor's last update on 10 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Development Grade II-IV Acute GVHD by Day +100 Following Transplantation (time frame: up to 100 days). 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 10 Feb 2026.