Immune Thrombocytopenia (ITP)Phase 2/3NCT04915482
TPO-RAs Combined With Anti-CD20 Antibody in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
A Phase 2/3 study testing Combined use of TPO-RAs with low-dose anti-CD20 antibody and The best available therapy in people with Immune Thrombocytopenia (ITP) and Autoantibodies, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immune Thrombocytopenia (ITP), Autoantibodies, Evan Syndrome
- What is being tested?
- Combined use of TPO-RAs with low-dose anti-CD20 antibody and The best available therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2021to 28 Feb 2025
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients have provided written informed consent prior to enrollment.
- 18-65 years old.
- Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.
- Platelet count<30 ×10^9/L at screening.
- Patients who have received at least one first-line treatment of ITP (glucocorticoid and / or intravenous immunoglobulin) in the past, failed (poor efficacy, or failure to maintain efficacy, or relapse), or had contraindications, intolerance, or refusal of first-line treatment.
- Treatment for ITP (including but not limited to glucocorticoids, recombinant human thrombopoietin (rTPO)) must be completed before enrollment, or the dose must be stable or in a phase of reduction within 2 weeks before enrollment. Immunosuppressants (including but not limited to azathioprine, danazol, cyclosporine A, mycophenolate mofetil) must be finished before entering the group, or the dose must be stable or in the reduction period within 3 months before entering the group.
- Effective contraceptive measures will be taken during the clinical trial.
Who cannot join
- Thrombocytopenia secondary to thyroid disease.
- Patients with any prior history of arterial or venous thrombosis, and with any of the following risk factors: cancer, Factor V Leiden, ATIII deficiency, and antiphospholipid syndrome.
- Those who had received anti-CD20 monoclonal antibody within 6 months or who had previously failed to respond to low-dose anti-CD20 monoclonal antibody.
- Patients who had failed to respond to the previous use of eltrombopag 75 mg once a day, hetrombopag 7.5mg once a day or avatrombopag 40mg once a day for more than 4 weeks.
- Patients who have received splenectomy within one year or have splenectomy plan within one year.
- Patients with lupus encephalopathy or lupus nephritis.
Show all 19Show fewer
- Patients with cataract.
- Patients with infectious fever (including but not limited to pulmonary infection) within 1 month or with active infection during screening.
- Existing hepatitis B virus, hepatitis C virus replication or HIV infection.
- Patients with agranulocytosis (ANC <1× 10^9/L), or moderate and severe anemia (HGB < 90g/L). For patients with Evans syndrome, patients with HGB< 60g/L will be excluded.
- Severe liver dysfunction (alanine aminotransferase or glutamic oxaloacetic transaminase > 3×ULN), or bilirubin level > 2×ULN except patients with Evans syndrome.
- Patients with severe cardiac or pulmonary dysfunction.
- Severe renal damage (creatinine clearance < 50 ml/min).
- There were surgical planners during the study.
- History of psychiatric disorder.
- Pregnant or lactating women or those planning to be pregnant during the trial.
- Patients with a history of drug/alcohol abuse (within 2 years before the study).
- Patients that have participated in other experimental researches within one month before enrollment.
- Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Rongfeng Fu, MD, +862223909009, furongfeng@ihcams.ac.cn
Lei Zhang, MD, +862223909240, zhanglei1@ihcams.ac.cn
About this study
Official title: Efficacy and Safety of TPO-RAs Combined With Anti-CD20 Antibody in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Failed to First-line Treatment: a Prospective, Open-label, Nonrandomized, Multicenter Clinical Trial
This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy（BAT）in adult immune thrombocytopenia with autoantibodies failed (due to intolerance or resistance) to first-line treatment.
Read the detailed description
This is a prospective, open-label, nonrandomized, multicenter clinical trial aiming at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy（BAT）in adult immune thrombocytopenia (ITP) with autoantibodies failed (due to intolerance or resistance) to first-line treatment. The subjects include ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.
Adult ITP patients with autoantibodies (18-65 years) will be nonrandomly divided into the following two treatment groups: 1. combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody. 2. the best available therapy（BAT）other than combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody.
The current treatment strategies and possible risks of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody in the treatment of ITP with autoantibodies will be fully introduced to the patients by the researchers. Then the patients will be divided into one of the two groups according to the patients' will.
- Being tested
- Combined use of TPO-RAs with low-dose anti-CD20 antibody, The best available therapy
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Evans Syndrome, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined use of TPO-RAs with low-dose anti-CD20 antibodyDrug
Experimental: Combined use of TPO-RAs with low-dose anti-CD20 antibody The starting dose of eltrombopag is 50-75mg once daily. The starting dose of hetrombopag is 5.0-7.5mg once daily. The starting dose of avatrombopag is 20-40mg once daily. Prior to or within 2 weeks after initiation of TPO-RAs therapy, a single dose of Rituximab at 375mg/m2 or divided doses of Rituximab at 100mg once a week for 2-4 weeks, or a single dose of ortuzumab at 1000mg can be administered.. The dosage will be adjusted according to the results of laboratory examinations and patient tolerance.
The best available therapyDrug
The best available therapy except for combined use of TPO-RAs with low-dose anti-CD20 antibody includes but not limited to glucocorticoids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO receptor agonists monotherapy, rituximab monotherapy, immunosuppressants, etc., and the researchers will adjust the treatment plan at any time according to the patient's condition.
| Study group | Role | What they receive |
|---|---|---|
| Combined use of TPO-RAs with low-dose anti-CD20 antibody | Experimental | The starting dose of eltrombopag is 50-75mg once daily. The starting dose of hetrombopag is 5.0-7.5mg once daily. The starting dose of avatrombopag is 20-40mg once daily. Prior to or within 2 weeks after initiation of TPO-RAs therapy, a single dose of Rituximab at 375mg/m2 or divided doses of Rituximab at 100mg once a week for 2-4 weeks, or a single dose of ortuzumab at 1000mg can be administered.. The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. Receives: Drug: Combined use of TPO-RAs with low-dose anti-CD20 antibody |
| The best available therapy other than combined use of TPO-RAs with low-dose anti-CD20 antibody | Active comparator | The best available therapy except for combined use of TPO-RAs with low-dose anti-CD20 antibody includes but not limited to glucocorticoids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO receptor agonists monotherapy, rituximab monotherapy, immunosuppressants, etc., and the researchers will adjust the treatment plan at any time according to the patient's condition. Receives: Drug: The best available therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet response
At weeks 4-24, the proportion of subjects with platelet count (PLT) ≥30×10^9/L and at least 2 times the baseline value in 4 out of 6 consecutive tests (at least 1 week interval between each test).
Measured: From the start of study treatment (Day 1) up to the end of week 24
Secondary outcomes (13)
Platelet response
Proportion of subjects who achieve response (R) within 4, 8 and 12 weeks of treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 4, 8 and 12
Platelet response
Proportion of subjects who achieve complete response (CR) within 4, 8 and 12 weeks of treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 4, 8 and 12
Time to platelet response
Time to response is defined as time from the start of treatment to the first time of achieving a platelet count ≥ 30×10^9/ L and at least doubling of the baseline count during the whole 24 weeks.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Duration of platelet response
Total duration of time a participant with a response of R.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Bleeding score
The incidence and grade of bleeding symptoms according to the World Health Organization Bleeding Scale.
Measured: From the start of study treatment (Day 1) up to the end of week 24
ITP-Patient Assessment Questionnaire
In all participants, ITP-Patient Assessment Questionnaire will be used to assess the health related quality of life before and after treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Changes of disease activity index in patients with systemic lupus erythematosus
The proportion of subjects with improvement of disease activity index in patients with systemic lupus erythematosus according to the SLEDAI standard.
Measured: From the start of study treatment (Day 1) up to the end of week 24
The improvement of symptoms
The proportion of subjects with improvement of symptoms including skin symptom, joint pain, dry mouth and dry eyes.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Improvement in immune indexes
The proportion of subjects with improvement immune indexes including antinuclear antibody, extractable nuclear antigens spectrum and Coomb's test.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Discontinuation rate of glucocorticoids
The proportion of subjects with discontinuation use of glucocorticoids.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Hemoglobin response
The proportion of subjects with Evans syndrome who have a hemoglobin level > 110g/L (female) or > 120g/L (male) in the absence of any recent transfusion and without ongoing hemolysis for 2 consecutive weeks (at least 1 week interval).
Measured: From the start of study treatment (Day 1) up to the end of week 24
Hemoglobin response
The proportion of subjects with Evans syndrome who have a hemoglobin level> 100g/L with at least a 20g/L increase from the pretreatment level for 2 consecutive weeks (at least 1 week interval).
Measured: From the start of study treatment (Day 1) up to the end of week 24
functional assessment of chronic illness therapy-fatigue
In all participants, functional assessment of chronic illness therapy-fatigue questionnaire will be used to assess the health related quality of life before and after treatment.
Measured: From the start of study treatment (Day 1) up to the end of week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start6 Jun 2021
- Primary completion31 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenia (ITP)Studies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, MD, Principal investigator, Institute of Hematology & Blood Diseases Hospital, ChinaRongfeng Fu, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915482
- Sponsor's protocol ID
- IIT2020034
- Status last verified
- Mar 2024
- First submitted
- 25 May 2021
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of TPO-RAs Combined With Anti-CD20 Antibody in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Failed to First-line Treatment: a Prospective, Open-label, Nonrandomized, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT04915482
- Acronym / sponsor ID
- IIT2020034
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 7 Jun 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.
This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy（BAT）in adult immune thrombocytopenia with autoantibodies failed (due to intolerance or resistance) to first-line treatment.
Detailed description
This is a prospective, open-label, nonrandomized, multicenter clinical trial aiming at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy（BAT）in adult immune thrombocytopenia (ITP) with autoantibodies failed (due to intolerance or resistance) to first-line treatment. The subjects include ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.
Adult ITP patients with autoantibodies (18-65 years) will be nonrandomly divided into the following two treatment groups: 1. combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody. 2. the best available therapy（BAT）other than combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody.
The current treatment strategies and possible risks of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody in the treatment of ITP with autoantibodies will be fully introduced to the patients by the researchers. Then the patients will be divided into one of the two groups according to the patients' will.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined use of TPO-RAs with low-dose anti-CD20 antibody | Experimental | Drug: Combined use of TPO-RAs with low-dose anti-CD20 antibodyThe starting dose of eltrombopag is 50-75mg once daily. The starting dose of hetrombopag is 5.0-7.5mg once daily. The starting dose of avatrombopag is 20-40mg once daily. Prior to or within 2 weeks after initiation of TPO-RAs therapy, a single dose of Rituximab at 375mg/m2 or divided doses of Rituximab at 100mg once a week for 2-4 weeks, or a single dose of ortuzumab at 1000mg can be administered.. The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. |
| The best available therapy other than combined use of TPO-RAs with low-dose anti-CD20 antibody | Active comparator | Drug: The best available therapyThe best available therapy except for combined use of TPO-RAs with low-dose anti-CD20 antibody includes but not limited to glucocorticoids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO receptor agonists monotherapy, rituximab monotherapy, immunosuppressants, etc., and the researchers will adjust the treatment plan at any time according to the patient's condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patients have provided written informed consent prior to enrollment.
- 18-65 years old.
- Diagnosed as ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome.
- Platelet count<30 ×10^9/L at screening.
- Patients who have received at least one first-line treatment of ITP (glucocorticoid and / or intravenous immunoglobulin) in the past, failed (poor efficacy, or failure to maintain efficacy, or relapse), or had contraindications, intolerance, or refusal of first-line treatment.
Key exclusion criteria (19 listed)
- Thrombocytopenia secondary to thyroid disease.
- Patients with any prior history of arterial or venous thrombosis, and with any of the following risk factors: cancer, Factor V Leiden, ATIII deficiency, and antiphospholipid syndrome.
- Those who had received anti-CD20 monoclonal antibody within 6 months or who had previously failed to respond to low-dose anti-CD20 monoclonal antibody.
- Patients who had failed to respond to the previous use of eltrombopag 75 mg once a day, hetrombopag 7.5mg once a day or avatrombopag 40mg once a day for more than 4 weeks.
- Patients who have received splenectomy within one year or have splenectomy plan within one year.
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 |
|---|---|---|
| Combined use of TPO-RAs with low-dose anti-CD20 antibodyExperimental: Combined use of TPO-RAs with low-dose anti-CD20 antibody The starting dose of eltrombopag is 50-75mg once daily. The starting dose of hetrombopag is 5.0-7.5mg once daily. The starting dose of avatrombopag is 20-40mg once daily. Prior to or within 2 weeks after initiation of TPO-RAs therapy, a single dose of Rituximab at 375mg/m2 or divided doses of Rituximab at 100mg once a week for 2-4 weeks, or a single dose of ortuzumab at 1000mg can be administered.. The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. | Drug | Combined use of TPO-RAs with low-dose anti-CD20 antibody |
| The best available therapyThe best available therapy except for combined use of TPO-RAs with low-dose anti-CD20 antibody includes but not limited to glucocorticoids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO receptor agonists monotherapy, rituximab monotherapy, immunosuppressants, etc., and the researchers will adjust the treatment plan at any time according to the patient's condition. | Drug | The best available therapy other than combined use of TPO-RAs with low-dose anti-CD20 antibody |
Primary outcome
Platelet response
Time frame: From the start of study treatment (Day 1) up to the end of week 24
At weeks 4-24, the proportion of subjects with platelet count (PLT) ≥30×10^9/L and at least 2 times the baseline value in 4 out of 6 consecutive tests (at least 1 week interval between each test).
13 secondary outcomes
Platelet response
Time frame: From the start of study treatment (Day 1) up to the end of week 4, 8 and 12
Platelet response
Time frame: From the start of study treatment (Day 1) up to the end of week 4, 8 and 12
Time to platelet response
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Duration of platelet response
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Bleeding score
Time frame: From the start of study treatment (Day 1) up to the end of week 24
ITP-Patient Assessment Questionnaire
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Changes of disease activity index in patients with systemic lupus erythematosus
Time frame: From the start of study treatment (Day 1) up to the end of week 24
The improvement of symptoms
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Improvement in immune indexes
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Discontinuation rate of glucocorticoids
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Hemoglobin response
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Hemoglobin response
Time frame: From the start of study treatment (Day 1) up to the end of week 24
functional assessment of chronic illness therapy-fatigue
Time frame: From the start of study treatment (Day 1) up to the end of week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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.
Lei Zhang, MD principal investigator
Institute of Hematology & Blood Diseases Hospital, China
Rongfeng Fu principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Combined use of TPO-RAs with low-dose anti-CD20 antibody and The best available therapy in people with Immune Thrombocytopenia (ITP) and Autoantibodies, run by Institute of Hematology & Blood Diseases Hospital, China 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 7 inclusion and 19 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 3 Jul 2024. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rongfeng Fu, MD (+862223909009, furongfeng@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet response (time frame: From the start of study treatment (Day 1) up to the end of week 24). 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 3 Jul 2024.