Deep Vein ThrombosisPhase 3DVTNCT04462003
Efficacy of Apixaban in Malignancy With Deep Venous Thrombosis
A Phase 3 study testing Apixaban and Enoxaparin in people with Deep Vein Thrombosis and Malignancy, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Deep Vein Thrombosis, Malignancy
- What is being tested?
- Apixaban and Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2019to 3 Jul 2020
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
- Previous DVT or venous thromboembolism
- Administration of LMWH or unfractionated heparin before randomization
- Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
- Thrombocytopenia (platelets <100 x 109L)
- Severe chronic kidney disease (estimated glomerular filtration rate <30 ml/minute)
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine,Beni-Suef University
Banī Suwayf, Beni Suweif Governorate, 62511
Mostafa O Mokadem, 00201009414408, mostafa.elmokadem9@gmail.com
mostafa.elmokadem9@gmail.com
About this study
Official title: Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.
Read the detailed description
Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) [1]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) [2]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence [3,4]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy [5]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy [6]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE [7]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).
- Conditions
- Deep Vein Thrombosis, Malignancy
- Being tested
- Apixaban, Enoxaparin
- Medical subject headings
- Venous Thrombosis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApixabanDrug
10 mg/12 h for 1 week followed by 5 mg/12 h
EnoxaparinDrug
1mg/Kg/sc/12h
| Study group | Role | What they receive |
|---|---|---|
| Apixaban | Active comparator | 50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily Receives: Drug: Apixaban |
| Enoxaparin | Active comparator | 50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h) Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent deep venous thrombosis or venous thromboembolism
New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
Measured: 6 months
Occurrence of fatal or major bleeding
Need for hospitalization, blood transfusion, surgical intervention or resulting into death
Measured: 6 months
Mortality related to massive pulmonary embolism
Death caused by hemodynamic instability secondary to massive pulmonary embolism
Measured: 6 months
Secondary outcomes (1)
Occurrence of non-fatal or minor bleeding
Bleeding that does not need hospitalization, blood transfusion, surgical intervention or resulting into death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start3 Jul 2019
- Primary completion2 Jul 2020 (estimated)
- Study completion3 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Deep Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa El Mokadem, Beni-Suef University
- Investigators
- Mostafa E Mokadem, Principal investigator, Faculty of Medicine, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462003
- Sponsor's protocol ID
- Apixaban in DVT with cancer
- Acronym
- DVT
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
PubMed 10737280Ay C, Beyer-Westendorf J, Pabinger I. Treatment of cancer-associated venous thromboembolism in the age of direct oral anticoagulants. Ann Oncol. 2019 Jun 1;30(6):897-907. doi: 10.1093/annonc/mdz111.
PubMed 30918939Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.
PubMed 10963635Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002 Nov 15;100(10):3484-8. doi: 10.1182/blood-2002-01-0108. Epub 2002 Jul 12.
PubMed 12393647Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.
PubMed 26867832Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
PubMed 31504429Agnelli G, Buller HR, Cohen A, Gallus AS, Lee TC, Pak R, Raskob GE, Weitz JI, Yamabe T. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/jth.13153. Epub 2015 Oct 29.
PubMed 26407753McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
PubMed 31630479Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Munoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thromb Haemost. 2018 Sep;118(9):1668-1678. doi: 10.1055/s-0038-1668523. Epub 2018 Aug 13.
PubMed 30103252Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017 Mar 21;23(11):1954-1963. doi: 10.3748/wjg.v23.i11.1954.
PubMed 28373761Desai J, Kolb JM, Weitz JI, Aisenberg J. Gastrointestinal bleeding with the new oral anticoagulants--defining the issues and the management strategies. Thromb Haemost. 2013 Aug;110(2):205-12. doi: 10.1160/TH13-02-0150. Epub 2013 May 23. No abstract available.
PubMed 23702623Desai J, Granger CB, Weitz JI, Aisenberg J. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc. 2013 Aug;78(2):227-39. doi: 10.1016/j.gie.2013.04.179. Epub 2013 May 29. No abstract available.
PubMed 23725876Cannon CP, Kohli P. Danger ahead: watch out for indirect comparisons! J Am Coll Cardiol. 2012 Aug 21;60(8):747-8. doi: 10.1016/j.jacc.2012.05.012. No abstract available.
PubMed 22898071Mokadem ME, Hassan A, Algaby AZ. Efficacy and safety of apixaban in patients with active malignancy and acute deep venous thrombosis. Vascular. 2021 Oct;29(5):745-750. doi: 10.1177/1708538120971148. Epub 2020 Nov 5.
PubMed 33153401
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Apixaban in Patients With Active Malignancy and Acute Deep Venous Thrombosis.
- ClinicalTrials.gov ID
- NCT04462003
- Acronym / sponsor ID
- DVT / Apixaban in DVT with cancer
- Conditions
- Deep Vein Thrombosis, Malignancy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 2 Jul 2020 (estimated)
- Study completion
- 3 Jul 2020 (estimated)
- First posted
- 8 Jul 2020 (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 aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH). It was hypothesised that Apixaban could be as effective as rivaroxiban and edoxaban in treatment of patients with acute DVT and active malignancy with a lower risk of bleeding especially in those with GIT cancer.
Detailed description
Patients with active malignancy have hypercoagulable state particularly, those receiving intravenous chemotherapy, with six fold higher risk of venous thromboembolism (VTE) [1]. Anticoagulation for malignancy associated deep venous thrombosis (DVT) can be difficult because of different limitations like bleeding, drug-drug interactions with chemotherapy and inconvenience with repeated subcutaneous injections of low-molecular-weight heparin (LMWH) [2]. In comparison with patients without active malignancy, patients with cancer who are on warfarin therapy have 2 to 6 folds more major bleeding events and 2 to 3 times more VTE recurrence [3,4]. The American College of Chest Physicians Guidelines recommended (LMWH) as standard therapy for management of acute VTE in patients with active malignancy [5]. Recently, Rivaroxiban and Edoxaban were considered as an alternative to weight-adjusted subcutaneous LMWH after pulmonary embolism in patients with active cancer without gastrointestinal (GIT) malignancy [6]. Apixaban is a direct factor Xa inhibitor approved by FDA for treatment of DVT and VTE [7]. However its efficacy in management of acute DVT and VTE associated with cancer is still unresolved issue. The aim of study was to evaluate the efficacy and safety of Apixaban in patients with acute deep venous thrombosis and active malignancy compared with weight adjusted subcutaneous (LMWH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apixaban | Active comparator | Drug: Apixaban50 patients with DVT with malignancy were randomized to apixaban 10 mg twice daily dose for 7 days followed by apixaban 5 mg twice daily |
| Enoxaparin | Active comparator | Drug: Enoxaparin50 patients with DVT with malignancy were randomized to enoxaparin (1mg/Kg/SC every 12 h) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Patients with pulmonary embolism and hemodynamic instability requiring thrombolytic therapy
- Previous DVT or venous thromboembolism
- Administration of LMWH or unfractionated heparin before randomization
- Brain tumours, cerebral metastes, hepatic tumours or impairment Child-Pugh B or C, -Recent or current active or life threating bleeding (e.g. intr acranial haemorrhage or gastrointestinal bleeding)
- Thrombocytopenia (platelets <100 x 109L)
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 |
|---|---|---|
| Apixaban10 mg/12 h for 1 week followed by 5 mg/12 h | Drug | Apixaban |
| Enoxaparin1mg/Kg/sc/12h | Drug | Enoxaparin |
Primary outcome
Recurrent deep venous thrombosis or venous thromboembolism
Time frame: 6 months
New or non resolving completely occluded deep venous thrombosis or occurrence of pulmonary embolism
Occurrence of fatal or major bleeding
Time frame: 6 months
Need for hospitalization, blood transfusion, surgical intervention or resulting into death
Mortality related to massive pulmonary embolism
Time frame: 6 months
Death caused by hemodynamic instability secondary to massive pulmonary embolism
1 secondary outcome
Occurrence of non-fatal or minor bleeding
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Results publication: PubMed 10737280Heit JA, Silverstein MD, Mohr DN, Petterson TM, O'Fallon WM, Melton LJ 3rd. Risk factors for deep vein thrombosis and pulmonary embolism: a population-based case-control study. Arch Intern Med. 2000 Mar 27;160(6):809-15. doi: 10.1001/archinte.160.6.809.
- Results publication: PubMed 30918939Ay C, Beyer-Westendorf J, Pabinger I. Treatment of cancer-associated venous thromboembolism in the age of direct oral anticoagulants. Ann Oncol. 2019 Jun 1;30(6):897-907. doi: 10.1093/annonc/mdz111.
- Results publication: PubMed 10963635Hutten BA, Prins MH, Gent M, Ginsberg J, Tijssen JG, Buller HR. Incidence of recurrent thromboembolic and bleeding complications among patients with venous thromboembolism in relation to both malignancy and achieved international normalized ratio: a retrospective analysis. J Clin Oncol. 2000 Sep;18(17):3078-83. doi: 10.1200/JCO.2000.18.17.3078.
- Results publication: PubMed 12393647Prandoni P, Lensing AW, Piccioli A, Bernardi E, Simioni P, Girolami B, Marchiori A, Sabbion P, Prins MH, Noventa F, Girolami A. Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosis. Blood. 2002 Nov 15;100(10):3484-8. doi: 10.1182/blood-2002-01-0108. Epub 2002 Jul 12.
- Results publication: PubMed 26867832Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, Huisman M, King CS, Morris TA, Sood N, Stevens SM, Vintch JRE, Wells P, Woller SC, Moores L. Antithrombotic Therapy for VTE Disease: CHEST Guideline and Expert Panel Report. Chest. 2016 Feb;149(2):315-352. doi: 10.1016/j.chest.2015.11.026. Epub 2016 Jan 7.
- Results publication: PubMed 31504429Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Results publication: PubMed 26407753Agnelli G, Buller HR, Cohen A, Gallus AS, Lee TC, Pak R, Raskob GE, Weitz JI, Yamabe T. Oral apixaban for the treatment of venous thromboembolism in cancer patients: results from the AMPLIFY trial. J Thromb Haemost. 2015 Dec;13(12):2187-91. doi: 10.1111/jth.13153. Epub 2015 Oct 29.
- Results publication: PubMed 31630479McBane RD 2nd, Wysokinski WE, Le-Rademacher JG, Zemla T, Ashrani A, Tafur A, Perepu U, Anderson D, Gundabolu K, Kuzma C, Perez Botero J, Leon Ferre RA, Henkin S, Lenz CJ, Houghton DE, Vishnu P, Loprinzi CL. Apixaban and dalteparin in active malignancy-associated venous thromboembolism: The ADAM VTE trial. J Thromb Haemost. 2020 Feb;18(2):411-421. doi: 10.1111/jth.14662. Epub 2019 Nov 28.
- Results publication: PubMed 30103252Agnelli G, Becattini C, Bauersachs R, Brenner B, Campanini M, Cohen A, Connors JM, Fontanella A, Gussoni G, Huisman MV, Lambert C, Meyer G, Munoz A, Abreu de Sousa J, Torbicki A, Verso M, Vescovo G; Caravaggio Study Investigators. Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thromb Haemost. 2018 Sep;118(9):1668-1678. doi: 10.1055/s-0038-1668523. Epub 2018 Aug 13.
- Results publication: PubMed 28373761Cheung KS, Leung WK. Gastrointestinal bleeding in patients on novel oral anticoagulants: Risk, prevention and management. World J Gastroenterol. 2017 Mar 21;23(11):1954-1963. doi: 10.3748/wjg.v23.i11.1954.
- Results publication: PubMed 23702623Desai J, Kolb JM, Weitz JI, Aisenberg J. Gastrointestinal bleeding with the new oral anticoagulants--defining the issues and the management strategies. Thromb Haemost. 2013 Aug;110(2):205-12. doi: 10.1160/TH13-02-0150. Epub 2013 May 23. No abstract available.
- Results publication: PubMed 23725876Desai J, Granger CB, Weitz JI, Aisenberg J. Novel oral anticoagulants in gastroenterology practice. Gastrointest Endosc. 2013 Aug;78(2):227-39. doi: 10.1016/j.gie.2013.04.179. Epub 2013 May 29. 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.
Mostafa E Mokadem principal investigator
Faculty of Medicine, Beni-Suef University
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 Apixaban and Enoxaparin in people with Deep Vein Thrombosis and Malignancy, run by Beni-Suef University at 1 site in Egypt.
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 0 inclusion and 7 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 8 Jul 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa O Mokadem (00201009414408, mostafa.elmokadem9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent deep venous thrombosis or venous thromboembolism (time frame: 6 months). The study lists 3 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 NCT04462003, which also lists 14 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 8 Jul 2020.