ThrombocytopeniaPhase 2ELPOTNCT03638817
Perioperative Eltrombopag in Patients With Inherited Thrombocytopenia
A Phase 2 study testing Eltrombopag in people with Thrombocytopenia, run by University Hospital, Toulouse at 25 sites in France.
Trial summary
The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected… Read more about this study
- Who is it for?
- Ages 6 to 75 years
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- Eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 25 sitesFrance
- Study dates
- 2 Aug 2019to 27 Jun 2023
- Phase
- Phase 2
- 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 6 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic patients with bleeding history and chronic thrombocytopenia with strong presumption of constitutional origin on the basis of
- the identified mutation and/or
- a combination of the following criteria: familial antecedent with Mendelian transmission, duration of thrombocytopenia, suggestive syndromic presentation, and evidence against primary or secondary immune thrombocytopenia, especially absence of immunologic markers and failure of previous conventional or immunosuppressive therapies.
- Averaged platelet counts during the last five years below the safety level required for the procedure.
- Scheduled (>4 weeks) surgery or invasive procedure with anticipated risk of bleeding: e.g. needle biopsy of solid organ (liver, kidney….etc.), interventional endoscopy, major surgeries, or surgery without possibility of mechanical control of haemostasis (e.g. tonsillectomy). Written informed consent of the patient or his (her) parents or tutors (patients < 18 yrs).
- Patients included in the French national registry of rare platelet disorders
- Patient with social insurance coverage
Who cannot join
- questionable constitutional origin;
- definite platelet dysfunction associated to thrombocytopenia (eg: gray platelet syndrome, NBEAL2 and related gene mutations, homozygous Bernard-Soulier Syndrome);
- thrombocytopenia with predisposition to hematologic malignancies (e.g; RUNX1, ETV6 or ANKRD26 gene mutations).
- amegakaryocytic thrombocytopenia resulting from mutations in the thrombopoietin (TPO) TPO-Mpl receptor, supposed, by definition, to be hardly responsive to receptor agonists.
- questionable requirement of prophylactic PC transfusions;
- procedure usually associated with platelet consumption requiring transfusions of PC (e.g.: cardiac surgery), making difficult the evaluation of success or failure;
Show all 21Show fewer
- procedures at risk of bleeding with immediate vital or functional consequences (e.g.: intra cranial surgery);
- personal history of arterial or venous thromboembolic events or known familial thrombophilia;
- association with another acquired or constitutional hemorrhagic diathesis;
- chronic hepatitis, cirrhosis, with moderate to severe liver failure (Child-Pugh score ≥5);
- previous or concurrent myeloid malignancy, including myelodysplastic syndrome;
- alanine aminotransferase (ALT) or bilirubin levels 2 times the upper limit of normal (ULN);
- altered renal function (creatinin clearance <30 ml/min);
- pregnancy (negative test required before inclusion in fertile women) or lactating women;
- refusal of safe contraception;
- ocular lenses opacity;
- hypersensitivity to eltrombopag or one of excipients;
- previous participation to the present study;
- current treatment with antiplatelet drugs, anticoagulants or direct acting antiviral agents approved for treatment of chronic hepatitis C infection;
- psychiatric, social or behavioral condition judged to be non-compatible with the respect of the protocol, including good observance of treatment and compliance to follow-up;
- adult protected by the law.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Angers Hospital
Angers
Bensancon Hospital
Besançon
Bordeaux Hospital
Bordeaux
Caen Hospital
Caen
Clermont-Ferrand Hospital
Clermont-Ferrand
Dijon Hospital
Dijon
Lille Hospital
Lille
Hospices Civils Lyon
Lyon
Marseille Hospital
Marseille
Montpellier Hospital
Montpellier
Nancy Hospital
Nancy
Nantes Hospital
Nantes
Cochin Hospital
Paris
Hopital Europeen G Pompidou
Paris
Kremlin Bicetre Hospital
Paris
Necker Hospital
Paris
Robert Debré Hospital
Paris
Trousseau Hospital
Paris
Poitiers Hospital
Poitiers
Reims Hospital
Reims
Rennes Hospital
Rennes
Rouen Hospital
Rouen
Strasbourg Hospital
Strasbourg
university hospital Toulouse
Toulouse
Tours Hospital
Tours
About this study
Official title: Evaluation of Perioperative Eltrombopag for the Management of Elective Surgery and Invasive Acts in Patients With Inherited Thrombocytopenia
The objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).
Read the detailed description
The hypothesis of the trial is that preoperative treatment by a thrombopoietin mimetic (eltrombopag) will be effective and safe and will avoid requirement of PC administration in a majority of IT patients Eltrombopag is a thrombopoietin mimetic available orally, not licenced for the treatment of IT. Preliminary data in short series of IT patients indicate that eltrombopag, at the doses used in primary immune thrombocytopenia, increases the platelet counts after 2-4 weeks of treatment and reduces spontaneous bleeding in a significant proportion of subjects. The tolerance of short-term treatment is good. The experience of eltrombopag for the management of perioperative thrombocytopenia in IT is anecdotic. Avoiding the administration of platelet concentrates in these patients, especially children, would represent a direct benefit by preventing adverse reactions to transfusion of blood products and human leukocyte antigen (HLA) immunisation.
Eltrombopag will be prescribed after the inclusion visit at the standard dose of 50 mg/day with dose adjustment on the platelet count (+/- 25 mg) after 2 weeks, for a maximum of 4 weeks before the invasive procedure. If the predefined safety level of platelet count required for the procedure is reached, the treatment will be discontinued and the patient operated without prophylactic administration of PC. In case of bleeding of undetermined cause per-and post-operatively, rescue PC will be given.
Clinical and biological follow-up will be performed until the end-of-study visit, 4 weeks after the intake of the last tablet of eltrombopag.
- Conditions
- Thrombocytopenia
- Being tested
- Eltrombopag
- Keywords
- Inherited thrombocytopenias (IT), Platelet concentrates (PC), Eltrombopag, Surgery, Invasive acts, Perioperative, Rare disease, Thrombopoietin mimetic
- Medical subject headings
- Thrombocytopenia, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Eltrombopag will be prescribed at doses recommended in primary immune thrombocytopenia (50, 25 or 75 mg), starting 4 weeks before the procedure and stopped 2 days before. PC will be administrated prophylactically if the platelet count is < 80 G/L or per/post-operatively in case of bleeding of undetermined cause.
Antifibrinolytics will be authorized and low molecular weight heparin prescribed if indicated for the prophylaxis of postoperative venous thrombosis according to the standard dose and duration, , irrespective of the platelet count
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | Not described Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative management by eltrombopag in inherited thrombocytopenia
The response to Eltrombopag is a composite criteria including the level of platelet count 2 days before the procedure and the requirement of PC administration at any time in the study period. The "study period" is running from the start of treatment (inclusion visit) to 4 weeks after completion of treatment. A platelet count remaining below 80 G/L preoperatively, whether or not eltrombopag was taken, is a criterion of failure of treatment.
Measured: up to 4 weeks after completion of treatment
Secondary outcomes (7)
Adverse events
Adverse events and adverse reactions occurring at any time during the study period will be collected. Adverse events may be clinical and biological (especially liver function tests).
Measured: up to 4 weeks after completion of treatment
Excessive bleeding
Excessive or unusual bleeding occurring at any time during the study period are major adverse events. An independent event adjudication committee (EAC) will review all bleeding events.
Measured: up to 4 weeks after completion of treatment
Vascular thrombosis
Symptomatic thrombosis (venous or arterial) occurring at any time during the study period will be diagnosed by appropriate objective methods and reviewed by the EAC.
Measured: up to 4 weeks after completion of treatment
Doses of eltrombopag on-treatment
The total doses of eltrombopag given in the preoperative period will be recorded, as the dose and duration of treatment required to obtained the safety level
Measured: 2 and 4 weeks after the beginning of the treatment
Platelet kinetics
Serial blood sampling during the study period will be performed for measuring the rise of platelet count on-treatment and its decline after completion of treatment.
Measured: up to 4 weeks after completion of treatment
Platelet size
Mean platelet volume will be measured by flow cytometry.on blood samples obtained for platelet counts at inclusion, during hospitalisation and end-of study visit
Measured: Inclusion and before the procedure
Baseline of Serum Thrombopoietin
Serum thrombopoietin will be measured once, at the inclusion visit.
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start2 Aug 2019
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- French network for inherited hemorragic diseases, National Reference Centre for Platelet Pathologies
- Responsible party
- Sponsor
- Investigators
- Pierre SIE, Prof., Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638817
- Sponsor's protocol ID
- RC31/16/8913
- Other IDs
- 2017-004489-88, 2017
- Acronym
- ELPOT
- Status last verified
- Aug 2024
- First submitted
- 29 Jun 2018
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pecci A, Gresele P, Klersy C, Savoia A, Noris P, Fierro T, Bozzi V, Mezzasoma AM, Melazzini F, Balduini CL. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. Blood. 2010 Dec 23;116(26):5832-7. doi: 10.1182/blood-2010-08-304725. Epub 2010 Sep 15.
PubMed 20844233Pecci A. Pathogenesis and management of inherited thrombocytopenias: rationale for the use of thrombopoietin-receptor agonists. Int J Hematol. 2013 Jul;98(1):34-47. doi: 10.1007/s12185-013-1351-7. Epub 2013 May 1.
PubMed 23636669Pecci A, Barozzi S, d'Amico S, Balduini CL. Short-term eltrombopag for surgical preparation of a patient with inherited thrombocytopenia deriving from MYH9 mutation. Thromb Haemost. 2012 Jun;107(6):1188-9. doi: 10.1160/TH12-01-0005. Epub 2012 Mar 8. No abstract available.
PubMed 22398565Gerrits AJ, Leven EA, Frelinger AL 3rd, Brigstocke SL, Berny-Lang MA, Mitchell WB, Revel-Vilk S, Tamary H, Carmichael SL, Barnard MR, Michelson AD, Bussel JB. Effects of eltrombopag on platelet count and platelet activation in Wiskott-Aldrich syndrome/X-linked thrombocytopenia. Blood. 2015 Sep 10;126(11):1367-78. doi: 10.1182/blood-2014-09-602573. Epub 2015 Jul 29.
PubMed 26224646Favier R, Feriel J, Favier M, Denoyelle F, Martignetti JA. First successful use of eltrombopag before surgery in a child with MYH9-related thrombocytopenia. Pediatrics. 2013 Sep;132(3):e793-5. doi: 10.1542/peds.2012-3807. Epub 2013 Aug 12.
PubMed 23940247Fiore M, Saut N, Alessi MC, Viallard JF. Successful use of eltrombopag for surgical preparation in a patient with ANKRD26-related thrombocytopenia. Platelets. 2016 Dec;27(8):828-829. doi: 10.1080/09537104.2016.1190446. Epub 2016 Jun 8. No abstract available.
PubMed 27276516Zhang J, Liang Y, Ai Y, Xie J, Li Y, Zheng W. Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review. Expert Opin Pharmacother. 2017 Oct;18(15):1543-1551. doi: 10.1080/14656566.2017.1373091. Epub 2017 Sep 4.
PubMed 28845713
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Eltrombopag for the Management of Elective Surgery and Invasive Acts in Patients With Inherited Thrombocytopenia
- ClinicalTrials.gov ID
- NCT03638817
- Acronym / sponsor ID
- ELPOT / RC31/16/8913
- Conditions
- Thrombocytopenia
- Keywords
- Inherited thrombocytopenias (IT), Platelet concentrates (PC), Eltrombopag, Surgery, Invasive acts, Perioperative, Rare disease, Thrombopoietin mimetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- French network for inherited hemorragic diseases, National Reference Centre for Platelet Pathologies
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 20 Aug 2018 (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 objective of the study is to estimate the response to eltrombopag based on platelet count increase above a safety level of 80 G/L and lack of requirement for pre-, per- and post-operative administration of platelet concentrates (PC) for performing elective invasive acts at mild or high bleeding risk,in selected patients with inherited thrombocytopenia (IT).
Detailed description
The hypothesis of the trial is that preoperative treatment by a thrombopoietin mimetic (eltrombopag) will be effective and safe and will avoid requirement of PC administration in a majority of IT patients Eltrombopag is a thrombopoietin mimetic available orally, not licenced for the treatment of IT. Preliminary data in short series of IT patients indicate that eltrombopag, at the doses used in primary immune thrombocytopenia, increases the platelet counts after 2-4 weeks of treatment and reduces spontaneous bleeding in a significant proportion of subjects. The tolerance of short-term treatment is good. The experience of eltrombopag for the management of perioperative thrombocytopenia in IT is anecdotic. Avoiding the administration of platelet concentrates in these patients, especially children, would represent a direct benefit by preventing adverse reactions to transfusion of blood products and human leukocyte antigen (HLA) immunisation.
Eltrombopag will be prescribed after the inclusion visit at the standard dose of 50 mg/day with dose adjustment on the platelet count (+/- 25 mg) after 2 weeks, for a maximum of 4 weeks before the invasive procedure. If the predefined safety level of platelet count required for the procedure is reached, the treatment will be discontinued and the patient operated without prophylactic administration of PC. In case of bleeding of undetermined cause per-and post-operatively, rescue PC will be given.
Clinical and biological follow-up will be performed until the end-of-study visit, 4 weeks after the intake of the last tablet of eltrombopag.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eltrombopag | Experimental | Drug: Eltrombopag |
Who may qualify
- Ages
- 6 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Symptomatic patients with bleeding history and chronic thrombocytopenia with strong presumption of constitutional origin on the basis of
- Averaged platelet counts during the last five years below the safety level required for the procedure.
- Scheduled (>4 weeks) surgery or invasive procedure with anticipated risk of bleeding: e.g. needle biopsy of solid organ (liver, kidney….etc.), interventional endoscopy, major surgeries, or surgery without possibility of mechanical control of haemostasis (e.g. tonsillectomy). Written informed consent of the patient or his (her) parents or tutors (patients < 18 yrs).
- Patients included in the French national registry of rare platelet disorders
- Patient with social insurance coverage
Key exclusion criteria (21 listed)
- questionable constitutional origin;
- definite platelet dysfunction associated to thrombocytopenia (eg: gray platelet syndrome, NBEAL2 and related gene mutations, homozygous Bernard-Soulier Syndrome);
- thrombocytopenia with predisposition to hematologic malignancies (e.g; RUNX1, ETV6 or ANKRD26 gene mutations).
- amegakaryocytic thrombocytopenia resulting from mutations in the thrombopoietin (TPO) TPO-Mpl receptor, supposed, by definition, to be hardly responsive to receptor agonists.
- questionable requirement of prophylactic PC transfusions;
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 |
|---|---|---|
| EltrombopagEltrombopag will be prescribed at doses recommended in primary immune thrombocytopenia (50, 25 or 75 mg), starting 4 weeks before the procedure and stopped 2 days before. PC will be administrated prophylactically if the platelet count is < 80 G/L or per/post-operatively in case of bleeding of undetermined cause. Antifibrinolytics will be authorized and low molecular weight heparin prescribed if indicated for the prophylaxis of postoperative venous thrombosis according to the standard dose and duration, , irrespective of the platelet count | Drug | Eltrombopag |
Primary outcome
Perioperative management by eltrombopag in inherited thrombocytopenia
Time frame: up to 4 weeks after completion of treatment
The response to Eltrombopag is a composite criteria including the level of platelet count 2 days before the procedure and the requirement of PC administration at any time in the study period. The "study period" is running from the start of treatment (inclusion visit) to 4 weeks after completion of treatment. A platelet count remaining below 80 G/L preoperatively, whether or not eltrombopag was taken, is a criterion of failure of treatment.
7 secondary outcomes
Adverse events
Time frame: up to 4 weeks after completion of treatment
Excessive bleeding
Time frame: up to 4 weeks after completion of treatment
Vascular thrombosis
Time frame: up to 4 weeks after completion of treatment
Doses of eltrombopag on-treatment
Time frame: 2 and 4 weeks after the beginning of the treatment
Platelet kinetics
Time frame: up to 4 weeks after completion of treatment
Platelet size
Time frame: Inclusion and before the procedure
Baseline of Serum Thrombopoietin
Time frame: Inclusion visit
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 27 Aug 2024.
- Background: PubMed 20844233Pecci A, Gresele P, Klersy C, Savoia A, Noris P, Fierro T, Bozzi V, Mezzasoma AM, Melazzini F, Balduini CL. Eltrombopag for the treatment of the inherited thrombocytopenia deriving from MYH9 mutations. Blood. 2010 Dec 23;116(26):5832-7. doi: 10.1182/blood-2010-08-304725. Epub 2010 Sep 15.
- Background: PubMed 23636669Pecci A. Pathogenesis and management of inherited thrombocytopenias: rationale for the use of thrombopoietin-receptor agonists. Int J Hematol. 2013 Jul;98(1):34-47. doi: 10.1007/s12185-013-1351-7. Epub 2013 May 1.
- Background: PubMed 22398565Pecci A, Barozzi S, d'Amico S, Balduini CL. Short-term eltrombopag for surgical preparation of a patient with inherited thrombocytopenia deriving from MYH9 mutation. Thromb Haemost. 2012 Jun;107(6):1188-9. doi: 10.1160/TH12-01-0005. Epub 2012 Mar 8. No abstract available.
- Background: PubMed 26224646Gerrits AJ, Leven EA, Frelinger AL 3rd, Brigstocke SL, Berny-Lang MA, Mitchell WB, Revel-Vilk S, Tamary H, Carmichael SL, Barnard MR, Michelson AD, Bussel JB. Effects of eltrombopag on platelet count and platelet activation in Wiskott-Aldrich syndrome/X-linked thrombocytopenia. Blood. 2015 Sep 10;126(11):1367-78. doi: 10.1182/blood-2014-09-602573. Epub 2015 Jul 29.
- Background: PubMed 23940247Favier R, Feriel J, Favier M, Denoyelle F, Martignetti JA. First successful use of eltrombopag before surgery in a child with MYH9-related thrombocytopenia. Pediatrics. 2013 Sep;132(3):e793-5. doi: 10.1542/peds.2012-3807. Epub 2013 Aug 12.
- Background: PubMed 27276516Fiore M, Saut N, Alessi MC, Viallard JF. Successful use of eltrombopag for surgical preparation in a patient with ANKRD26-related thrombocytopenia. Platelets. 2016 Dec;27(8):828-829. doi: 10.1080/09537104.2016.1190446. Epub 2016 Jun 8. No abstract available.
- Background: PubMed 28845713Zhang J, Liang Y, Ai Y, Xie J, Li Y, Zheng W. Thrombopoietin-receptor agonists for children with immune thrombocytopenia: a systematic review. Expert Opin Pharmacother. 2017 Oct;18(15):1543-1551. doi: 10.1080/14656566.2017.1373091. Epub 2017 Sep 4.
- 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.
Pierre SIE, Prof. principal investigator
University Hospital, Toulouse
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eltrombopag in people with Thrombocytopenia, run by University Hospital, Toulouse at 25 sites in France.
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 21 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 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Perioperative management by eltrombopag in inherited thrombocytopenia (time frame: up to 4 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03638817, which also lists 7 linked publications.
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 27 Aug 2024.