Autoimmune Hemolytic AnemiaDRAIHANCT04024202
Data Registry of Auto Immune Hemolytic Anemia
An observational study of Autoimmune Hemolytic Anemia, run by Sanquin Research & Blood Bank Divisions at 2 sites in Netherlands.
Trial summary
In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000 individuals. Read more about this study
- Who is it for?
- Ages 3 months and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- How many people
- 720 participants
- Where
- 2 sitesNetherlands
- Study dates
- 12 Jul 2019to 1 Dec 2024
- Phase
- Observational
- 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 3 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients, from the age of 3 months, with a positive DAT a positive eluate and signs of hemolysis and patients with a positive DAT for complement only with a negative eluate but with signs of hemolysis, and blood donors with a positive DAT and a positive eluate and/or clinically relevant cold autoantibodies.
Who may be able to join
- Sufficient comprehension of the Dutch language
- Signed informed consent by patient and/or parent/caretaker or donor
- Patients older than 3 months
- Patients with a positive DAT, a positive eluate and signs of hemolysis*
- Patients with a positive DAT with complement only, negative eluate, but with signs of hemolysis
- Donors with a (repeatedly) positive DAT and a positive eluate and/or clinically relevant cold auto-antibodies
Who cannot join
- Prior inclusion in the DRAIHA study
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
AMC
Amsterdam-Zuidoost
- Recruiting
UMC Radboud
Nijmegen
About this study
Official title: The DRAIHA Study: Data Registry of AutoImmune Hemolytic Anemia, to Improve Diagnostic Testing for the Development of Personalized Treatment Protocols in AIHA Patients
In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000 individuals. An unsolved difficulty in diagnosis of AIHA is the laboratory test accuracy. The current 'golden standard' for AIHA is the direct antiglobulin test (DAT). The DAT detects autoantibody- and/or complement-opsonized RBCs. The DAT has insufficient test characteristics since it remains falsely negative in approximate 5-10% of patients with AIHA, whereas a falsely positive DAT can be found in 8% of hospitalized individuals. Also apparently healthy blood donors can have a positive DAT. The consequences of DAT positivity are not well known and may point to early, asymptomatic disease, or to another disease associated with formation of RBC autoantibodies, such as a malignancy or (systemic) autoimmune disease. Currently, there are no guidelines to follow-up DAT positive donors.
A second unsolved difficulty is the choice of treatment in AIHA. Hemolysis can be stopped or at least attenuated with corticosteroids, aiming to inhibit autoantibody production and/or RBC destruction. Many patients do not respond adequately to corticosteroid treatment or develop severe side effects.
Read more
Currently, it is advised to avoid RBC transfusions since these may lead to aggravation of hemolysis and RBC alloantibody formation. But in case symptomatic anemia occurs, RBC transfusions need to be given. An evidence-based transfusion strategy for AIHA patients is needed to warrant safe transfusion in this complex patient group.
To design optimal diagnostic testing and (supportive) treatment algorithms, the investigators will study a group well-characterized patients with AIHA and blood donors without AIHA, via a prospective centralized clinical data collection and evaluation of new laboratory tests. With this data the knowledge of the AIHA pathophysiology and to evaluate diagnostic testing in correlation with clinical features and treatment outcome can be improved.
- Conditions
- Autoimmune Hemolytic Anemia
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | 1. Patients with a positive DAT, a positive eluate and signs of hemolysis 2. Patients with a positive DAT with complement only, negative eluate, but with hemolysis | |
| Blood donors | Blood donors with a positive direct antiglobulin test and a positive eluate and/or clinically relevant cold auto-antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological characteristics of autoantibodies in autoimmune hemolytic anemia (AIHA) patients - laboratory tests.
Documentation of characteristics of autoantibodies (e.g. isotype, subtype, titer, thermal amplitude).
Measured: 12-18 months
Assessment of hemolysis before and after therapy, reported per class of auto-immune hemolytic anemia. - laboratory tests
Documentation of hemolysis parameters (hemoglobin level (g/dL), reticulocytes (%), haptoglobin (mg/dL), bilirubin (μmol/L) and LDH(U/L)) before and after each type of therapy. AIHA classification as IgG/IgA only, IgG/IgA with complement activation or complement activation only.
Measured: 12-18 months
Secondary outcomes (8)
Incidence of underlying disease that causes or is associated with AIHA.
Documentation of physician-reported underlying disease that caused AIHA (e.g. autoimmune and/or lymphoproliferative disease, infection, medication).
Measured: 12-18 months
Type of treatment prescribed as first-line, second-line or further-line treatment for AIHA.
The percentage of patients receiving first, second or further-line treatment for AIHA will be calculated.
Measured: 12-18 months
Hematological response after each treatment line (CR, CR-u, PR and NR)
Percentage of patients with CR, CR-u, PR and NR after each treatment line. Hematological response will be classified as CR (complete remission), CR-u (CR- undetermined), PR (partial response) and NR (no response).
CR: normal hemoglobin, no signs of hemolysis (normal haptoglobin, normal amount of reticulocytes, bilirubin, LDH), no treatment and transfusion independence during the last 4 weeks.
CR-u: as CR, but hemoglobin, reticulocytes, LDH and/or bilirubin are deviating through another reason (e.g. underlying malignant disease).
PR: 1. Hemoglobin > 10g/dL, no signs of hemolysis, transfusion independent, but a continuous treatment with low dose prednisone (< 10 mg/day) or other immunosuppressive therapy is necessary. 2. Compensated hemolytic anemia with an stable hemoglobin >10g/dL, transfusion independent, maximal dose of prednisone < 10mg/day or other continuous immunosuppressive therapy or EPO.
NR: no PR reached
Measured: 12-18 months
Relapse-free survival, defined as the time since the achievement of complete or partial remission until relapse of AIHA or dead from any cause.
Relapse-free survival will be calculated as the time since the achievement of complete or partial remission until relapse of AIHA or dead from any cause. Median RFS and 95% CI will be calculated.
Measured: 12-18 month
Documentation of adverse events during the treatment of AIHA.
Documentation of adverse events during the treatment of AIHA indicated according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE) Publish Date: May 28, 2009
Measured: 12-18 month
Assessment of hemolysis parameters after red blood cell transfusion.
Documentation of hemolysis parameters (hemoglobin level (g/dL), reticulocytes (%), haptoglobin (mg/dL), bilirubin (μmol/L) and LDH (U/L)) before red blood cell transfusion.
Measured: 1 and 7 days after transfusion
Change in the incidence of auto- and alloantibodies after red blood cell transfusion.
Compare the incidence of auto- and alloantibodies before and after red blood cell transfusion.
Measured: 12-18 months
Characteristics of autoantibodies of DAT positive blood donors.
Documentation of characteristics of autoantibodies (e.g. isotype, subtype, titer, thermal amplitude) of DAT positive blood donors.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start12 Jul 2019
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanquin Research & Blood Bank Divisions
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Radboud University Medical Center, UMC Utrecht, Maastricht University Medical Center, Erasmus Medical Center, Haga Hospital, Isala, Jeroen Bosch Ziekenhuis, St. Antonius Hospital, Onze Lieve Vrouwe Gasthuis, Spaarne Gasthuis, Amsterdam University Medical Center, Prothya Biosolutions
- Responsible party
- Sponsor
- Investigators
- M. De Haas, Prof. MD PhD, Principal investigator, Center for Clinical Transfusion Research (CCTR), Sanquin, The NetherlandsS.S Zeerleder, Prof. MD PhD, Principal investigator, University Hospital, University of Bern, Switzerland and Department for BioMedical Research, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024202
- Sponsor's protocol ID
- PPOC 15-27
- Acronym
- DRAIHA
- Status last verified
- Jul 2019
- First submitted
- 31 May 2019
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garratty G. Immune hemolytic anemia associated with negative routine serology. Semin Hematol. 2005 Jul;42(3):156-64. doi: 10.1053/j.seminhematol.2005.04.005.
PubMed 16041665Freedman J. False-positive antiglobulin tests in healthy subjects and in hospital patients. J Clin Pathol. 1979 Oct;32(10):1014-8. doi: 10.1136/jcp.32.10.1014.
PubMed 521494Barcellini W, Fattizzo B, Zaninoni A, Radice T, Nichele I, Di Bona E, Lunghi M, Tassinari C, Alfinito F, Ferrari A, Leporace AP, Niscola P, Carpenedo M, Boschetti C, Revelli N, Villa MA, Consonni D, Scaramucci L, De Fabritiis P, Tagariello G, Gaidano G, Rodeghiero F, Cortelezzi A, Zanella A. Clinical heterogeneity and predictors of outcome in primary autoimmune hemolytic anemia: a GIMEMA study of 308 patients. Blood. 2014 Nov 6;124(19):2930-6. doi: 10.1182/blood-2014-06-583021. Epub 2014 Sep 16.
PubMed 25232059Rottenberg Y, Yahalom V, Shinar E, Barchana M, Adler B, Paltiel O. Blood donors with positive direct antiglobulin tests are at increased risk for cancer. Transfusion. 2009 May;49(5):838-42. doi: 10.1111/j.1537-2995.2008.02054.x. Epub 2009 Jan 2.
PubMed 19170992Meulenbroek EM, de Haas M, Brouwer C, Folman C, Zeerleder SS, Wouters D. Complement deposition in autoimmune hemolytic anemia is a footprint for difficult-to-detect IgM autoantibodies. Haematologica. 2015 Nov;100(11):1407-14. doi: 10.3324/haematol.2015.128991. Epub 2015 Sep 9.
PubMed 26354757Zanella A, Barcellini W. Treatment of autoimmune hemolytic anemias. Haematologica. 2014 Oct;99(10):1547-54. doi: 10.3324/haematol.2014.114561.
PubMed 25271314Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.
PubMed 25497766Shi J, Rose EL, Singh A, Hussain S, Stagliano NE, Parry GC, Panicker S. TNT003, an inhibitor of the serine protease C1s, prevents complement activation induced by cold agglutinins. Blood. 2014 Jun 26;123(26):4015-22. doi: 10.1182/blood-2014-02-556027. Epub 2014 Apr 2.
PubMed 24695853Wouters D, Stephan F, Strengers P, de Haas M, Brouwer C, Hagenbeek A, van Oers MH, Zeerleder S. C1-esterase inhibitor concentrate rescues erythrocytes from complement-mediated destruction in autoimmune hemolytic anemia. Blood. 2013 Feb 14;121(7):1242-4. doi: 10.1182/blood-2012-11-467209. No abstract available.
PubMed 23411737
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The DRAIHA Study: Data Registry of AutoImmune Hemolytic Anemia, to Improve Diagnostic Testing for the Development of Personalized Treatment Protocols in AIHA Patients
- ClinicalTrials.gov ID
- NCT04024202
- Acronym / sponsor ID
- DRAIHA / PPOC 15-27
- Conditions
- Autoimmune Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- Sanquin Research & Blood Bank DivisionsUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Radboud University Medical Center, UMC Utrecht, Maastricht University Medical Center, Erasmus Medical Center, Haga Hospital, Isala, Jeroen Bosch Ziekenhuis, St. Antonius Hospital, Onze Lieve Vrouwe Gasthuis, Spaarne Gasthuis, Amsterdam University Medical Center, Prothya Biosolutions
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 18 Jul 2019 (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.
In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000 individuals. An unsolved difficulty in diagnosis of AIHA is the laboratory test accuracy. The current 'golden standard' for AIHA is the direct antiglobulin test (DAT). The DAT detects autoantibody- and/or complement-opsonized RBCs. The DAT has insufficient test characteristics since it remains falsely negative in approximate 5-10% of patients with AIHA, whereas a falsely positive DAT can be found in 8% of hospitalized individuals. Also apparently healthy blood donors can have a positive DAT. The consequences of DAT positivity are not well known and may point to early, asymptomatic disease, or to another disease associated with formation of RBC autoantibodies, such as a malignancy or (systemic) autoimmune disease. Currently, there are no guidelines to follow-up DAT positive donors.
A second unsolved difficulty is the choice of treatment in AIHA. Hemolysis can be stopped or at least attenuated with corticosteroids, aiming to inhibit autoantibody production and/or RBC destruction. Many patients do not respond adequately to corticosteroid treatment or develop severe side effects.
Currently, it is advised to avoid RBC transfusions since these may lead to aggravation of hemolysis and RBC alloantibody formation. But in case symptomatic anemia occurs, RBC transfusions need to be given. An evidence-based transfusion strategy for AIHA patients is needed to warrant safe transfusion in this complex patient group.
To design optimal diagnostic testing and (supportive) treatment algorithms, the investigators will study a group well-characterized patients with AIHA and blood donors without AIHA, via a prospective centralized clinical data collection and evaluation of new laboratory tests. With this data the knowledge of the AIHA pathophysiology and to evaluate diagnostic testing in correlation with clinical features and treatment outcome can be improved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –1. Patients with a positive DAT, a positive eluate and signs of hemolysis 2. Patients with a positive DAT with complement only, negative eluate, but with hemolysis |
| Blood donors | – | –Blood donors with a positive direct antiglobulin test and a positive eluate and/or clinically relevant cold auto-antibodies |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, from the age of 3 months, with a positive DAT a positive eluate and signs of hemolysis and patients with a positive DAT for complement only with a negative eluate but with signs of hemolysis, and blood donors with a positive DAT and a positive eluate and/or clinically relevant cold autoantibodies.
Key inclusion criteria (6 listed)
- Sufficient comprehension of the Dutch language
- Signed informed consent by patient and/or parent/caretaker or donor
- Patients older than 3 months
- Patients with a positive DAT, a positive eluate and signs of hemolysis*
- Patients with a positive DAT with complement only, negative eluate, but with signs of hemolysis
Key exclusion criteria (1 listed)
- Prior inclusion in the DRAIHA study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Immunological characteristics of autoantibodies in autoimmune hemolytic anemia (AIHA) patients - laboratory tests.
Time frame: 12-18 months
Documentation of characteristics of autoantibodies (e.g. isotype, subtype, titer, thermal amplitude).
Assessment of hemolysis before and after therapy, reported per class of auto-immune hemolytic anemia. - laboratory tests
Time frame: 12-18 months
Documentation of hemolysis parameters (hemoglobin level (g/dL), reticulocytes (%), haptoglobin (mg/dL), bilirubin (μmol/L) and LDH(U/L)) before and after each type of therapy. AIHA classification as IgG/IgA only, IgG/IgA with complement activation or complement activation only.
8 secondary outcomes
Incidence of underlying disease that causes or is associated with AIHA.
Time frame: 12-18 months
Type of treatment prescribed as first-line, second-line or further-line treatment for AIHA.
Time frame: 12-18 months
Hematological response after each treatment line (CR, CR-u, PR and NR)
Time frame: 12-18 months
Relapse-free survival, defined as the time since the achievement of complete or partial remission until relapse of AIHA or dead from any cause.
Time frame: 12-18 month
Documentation of adverse events during the treatment of AIHA.
Time frame: 12-18 month
Assessment of hemolysis parameters after red blood cell transfusion.
Time frame: 1 and 7 days after transfusion
Change in the incidence of auto- and alloantibodies after red blood cell transfusion.
Time frame: 12-18 months
Characteristics of autoantibodies of DAT positive blood donors.
Time frame: 12-18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2019.
- Background: PubMed 16041665Garratty G. Immune hemolytic anemia associated with negative routine serology. Semin Hematol. 2005 Jul;42(3):156-64. doi: 10.1053/j.seminhematol.2005.04.005.
- Background: PubMed 521494Freedman J. False-positive antiglobulin tests in healthy subjects and in hospital patients. J Clin Pathol. 1979 Oct;32(10):1014-8. doi: 10.1136/jcp.32.10.1014.
- Background: PubMed 25232059Barcellini W, Fattizzo B, Zaninoni A, Radice T, Nichele I, Di Bona E, Lunghi M, Tassinari C, Alfinito F, Ferrari A, Leporace AP, Niscola P, Carpenedo M, Boschetti C, Revelli N, Villa MA, Consonni D, Scaramucci L, De Fabritiis P, Tagariello G, Gaidano G, Rodeghiero F, Cortelezzi A, Zanella A. Clinical heterogeneity and predictors of outcome in primary autoimmune hemolytic anemia: a GIMEMA study of 308 patients. Blood. 2014 Nov 6;124(19):2930-6. doi: 10.1182/blood-2014-06-583021. Epub 2014 Sep 16.
- Background: PubMed 19170992Rottenberg Y, Yahalom V, Shinar E, Barchana M, Adler B, Paltiel O. Blood donors with positive direct antiglobulin tests are at increased risk for cancer. Transfusion. 2009 May;49(5):838-42. doi: 10.1111/j.1537-2995.2008.02054.x. Epub 2009 Jan 2.
- Background: PubMed 26354757Meulenbroek EM, de Haas M, Brouwer C, Folman C, Zeerleder SS, Wouters D. Complement deposition in autoimmune hemolytic anemia is a footprint for difficult-to-detect IgM autoantibodies. Haematologica. 2015 Nov;100(11):1407-14. doi: 10.3324/haematol.2015.128991. Epub 2015 Sep 9.
- Background: PubMed 25271314Zanella A, Barcellini W. Treatment of autoimmune hemolytic anemias. Haematologica. 2014 Oct;99(10):1547-54. doi: 10.3324/haematol.2014.114561.
- Background: PubMed 25497766Reynaud Q, Durieu I, Dutertre M, Ledochowski S, Durupt S, Michallet AS, Vital-Durand D, Lega JC. Efficacy and safety of rituximab in auto-immune hemolytic anemia: A meta-analysis of 21 studies. Autoimmun Rev. 2015 Apr;14(4):304-13. doi: 10.1016/j.autrev.2014.11.014. Epub 2014 Dec 9.
- Background: PubMed 24695853Shi J, Rose EL, Singh A, Hussain S, Stagliano NE, Parry GC, Panicker S. TNT003, an inhibitor of the serine protease C1s, prevents complement activation induced by cold agglutinins. Blood. 2014 Jun 26;123(26):4015-22. doi: 10.1182/blood-2014-02-556027. Epub 2014 Apr 2.
- Background: PubMed 23411737Wouters D, Stephan F, Strengers P, de Haas M, Brouwer C, Hagenbeek A, van Oers MH, Zeerleder S. C1-esterase inhibitor concentrate rescues erythrocytes from complement-mediated destruction in autoimmune hemolytic anemia. Blood. 2013 Feb 14;121(7):1242-4. doi: 10.1182/blood-2012-11-467209. No abstract available.
- 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.
M. De Haas, Prof. MD PhD principal investigator
Center for Clinical Transfusion Research (CCTR), Sanquin, The Netherlands
S.S Zeerleder, Prof. MD PhD principal investigator
University Hospital, University of Bern, Switzerland and Department for BioMedical Research, University of Bern, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hemolytic Anemia, run by Sanquin Research & Blood Bank Divisions at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 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 19 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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.
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 M. Jalink, MD (+31205123373, m.jalink@sanquin.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological characteristics of autoantibodies in autoimmune hemolytic anemia (AIHA) patients - laboratory tests. (time frame: 12-18 months). The study lists 2 primary outcomes in all. 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 NCT04024202, which also lists 9 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 19 Jul 2019.