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Cancer-associated ThrombosisPhase 3API-CATNCT03692065

API-CAT STUDY for APIxaban Cancer Associated Thrombosis

A Phase 3 study testing Apixaban 5 MG in people with Cancer-associated Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 114 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer-associated Thrombosis
What is being tested?
Apixaban 5 MG
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,766 participants
Where
114 sitesin 11 countries
Study dates
11 Oct 2018to 20 Oct 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Any cancer diagnosed histologically (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intra-cerebral metastasis)
  • Active cancer defined as the presence of measurable disease or ongoing (or planned) chemotherapy, radiotherapy, hormonotherapy, targeted therapy, immunotherapy at inclusion
  • Objectively documented index event : Symptomatic or incidental proximal lower-limb, iliac, inferior vena cava DVT or symptomatic or incidental pulmonary embolism in a segmental or larger pulmonary artery or incidental PE in a segmental or larger pulmonary artery
  • Proximal DVT is defined as DVT that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography or contrast enhanced computed tomography or magnetic resonance imaging
  • PE has to be demonstrated by imaging as follows:
Show all 14Show fewer
  • an intraluminal filling defect in segmental or more proximal branches on contrast enhanced chest computed tomography or on computed tomography pulmonary angiography; or
  • an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
  • a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
  • Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of his or her malignancy or other reasons but not for a VTE suspicion(e.g. cancer diagnosis or staging).
  • Completed at least 6 months of anticoagulant therapy at therapeutic dosage (whatever the drug and the dosing),or completed assigned a clinical trial study treatment, for the treatment of the index event and patient still receiving anticoagulant treatment 6 months after occurrence of the VTE index
  • No objectively documented symptomatic recurrence of VTE between the index event and randomization.
  • Anticipated duration of anticoagulant treatment of at least 12 months at the time of randomization
  • Patient affiliated to social security for French centers.

Who cannot join

  • WOCBP who are unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (condoms)] to avoid pregnancy for the entire study
  • Women who are pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to investigational product administration
  • Isolated sub-segmental (incidental or symptomatic) PE without associated DVT
  • Isolated distal DVT of the legs
  • Isolated upper-extremity DVT or superior vena cava thrombosis
Show all 35Show fewer
  • Isolated visceral thrombosis
  • Isolated catheter thrombosis
  • Objectively documented symptomatic recurrence of VTE after the index event under anticoagulant treatment
  • VTE during anticoagulant treatment given at therapeutic dosage
  • Subjects with indications for long-term treatment with a VKA, such as:
  • Mechanical heart valve
  • Antiphospholipid syndrome
  • Subjects with indication for long-term anticoagulation with a VKA or a DOAC at therapeutic dosage
  • Conditions increasing the risk of serious bleeding
  • intracranial or intraocular bleeding within the 6 months
  • major surgery within 2 weeks prior to randomization
  • overt major bleeding at time of randomization
  • Life expectancy < 12 months
  • Eastern Cooperative Oncology Group (ECOG) level 3 or 4
  • Bacterial endocarditis
  • Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg
  • Platelet count < 75,000/mm3
  • Hemoglobin < 8g /dl
  • Creatinine clearance < 30 ml /min based on the Cockcroft Gault equation
  • Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range
  • Subjects requiring acetylsalicylic acid >165 mg/day at randomization or thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor).
  • Subjects requiring dual anti-platelet therapy (such as acetylsalicylic acid plus clopidogrel or acetylsalicylic acid plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial.
  • Concomitant use of strong inhibitors of both cytochrome P-450 3A4 and P Glycoprotein (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole) or strong inducers of both cytochrome P450 3A4 and P Glycoprotein (e.g.,rifampicin, carbamazepine, or phenytoin).
  • Prisoners or subjects who are involuntarily incarcerated
  • Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
  • Hypersensitivity to apixaban
  • Subjects participating in another pharmaco therapeutic program with an experimental therapy that is known to affect the coagulation system
  • Under 18 years old
  • Patients under legal protection (guardianship).

Trial locations and contacts

114 sites in 11 countries.

114 sites in 11 countries

France68 sites

  • C.H.U. D'Amiens Picardie

    Amiens, 80054

  • Chu D'Angers

    Angers, 49033

  • HÔPITAL PRIVÉ ARRAS LES BONNETTES - Espace Artois Santé

    Arras, 62012

  • Centre Hospitalier d'Avignon

    Avignon, 84000

  • Institut Sainte Catherine

    Avignon, 84918

  • Hopital Jean Minjoz

    Besançon, 25030

  • Hôpital AVICENNE - APHP

    Bobigny, 93009

  • Hopital Saint Andre

    Bordeaux, 33075

  • Institut Bergonie

    Bordeaux, 33076

  • Hôpital d'Instruction des Armées Clermont Tonnerre

    Brest, 29240

  • Chru Brest - Hopital Morvan

    Brest, 29609

  • Chru Brest- Hopital Cavale Blanche

    Brest, 29609

  • Centre François Baclesse

    Caen, 14000

  • Centre de Recherche Clinique

    Caen, 14033

  • Hopital Cote de Nacre

    Caen, 14033

  • Clinique Du Parc

    Castelnau-le-Lez, 34171

  • Centre hospitalier Métropole Savoie

    Chambéry, 73000

  • Ch Cholet

    Cholet, 49300

  • Hia Percy

    Clamart, 92190

  • Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • Hôpital BEAUJON - APHP

    Clichy, 92110

  • Hopital Louis Mourier - APHP

    Colombes, Île-de-France Region, 92700

  • Hôpital Henri Mondor

    Créteil, 94000

  • Hôpital HENRI MONDOR - APHP

    Créteil, 94010

  • CHU DIJON BOURGOGNE - Hôpital François Mitterrand

    Dijon, 21079

  • Chu de Grenoble

    Grenoble, 38043

  • Chd Vendee

    La Roche-sur-Yon, 85025

  • Centre Hospitalier Du Mans

    Le Mans, 72037

  • Centre hospitalier Emile Roux

    Le Puy-en-Velay, 43000

  • Chu de Limoges

    Limoges, 87042

  • Centre Leon Berard

    Lyon, 69008

  • Hôpital Prive Jean Mermoz

    Lyon, 69008

  • Clinique de l'Infirmerie Protestante de Lyon

    Lyon, 69300

  • Hopital La Timone Adultes

    Marseille, 13385

  • Groupe hospitalier sud Ile de France

    Melun, 77000

  • Hopital Saint- Eloi

    Montpellier, 34000

  • C.H. Des Pays de Morlaix

    Morlaix, 29600

  • Centre D Oncologie de Gentilly

    Nancy, 54000

  • CHU DE Nantes - Site Hotel Dieu

    Nantes, 44035

  • Chu de Nice

    Nice, 06001

  • Institut Curie

    Paris, 75005

  • Hôpital Saint Antoine - APHP

    Paris, 75012

  • Hôpital PITIE SALPETRIERE - APHP

    Paris, 75013

  • Hôpital COCHIN - APHP

    Paris, 75014

  • Hôpital GEORGES POMPIDOU - APHP

    Paris, 75015

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hopital Tenon - Aphp

    Paris, 75020

  • Hopital Saint-Joseph

    Paris, 75674

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Polyclinique de Courlancy

    Reims, 51057

  • CHU de Rennes

    Rennes, 35000

  • Centre Anti-Cancereux E. Marquis

    Rennes, 35042

  • Chu de Rouen - Hopital Charles Nicolle

    Rouen, 76038

  • Centre Rene Huguenin

    Saint-Cloud, 92210

  • Hôpital Nord

    Saint-Etienne, 42055

  • C.H.I Poissy-Saint Germain

    Saint-Germain-en-Laye, 78105

  • Centre Hospitalier de Saint Malo

    St-Malo, 35400

  • Clinique de l' Estrée

    Stains, 93240

  • Clinique Saint Anne

    Strasbourg, 67000

  • Centre Paul Strauss

    Strasbourg, 67085

  • Hopital Foch

    Suresnes, 92151

  • Chi de Toulon La Seyne

    Toulon, 83056

  • Iuct Oncopole

    Toulouse, 31059

  • Hopital Andre Mignot

    Versailles, 78000

  • L'Hôpital Nord-Ouest

    Villefranche-sur-Saône, 69655

  • Hôpital Paul Brousse - APHP

    Villejuif, 94800

  • Institut Gustave Roussy

    Villejuif, 94805

  • Médipôle Hôpital Mutualiste

    Villeurbanne, 69616

Other trials in France

Spain11 sites

  • Hospital genarl Univ de Albacete

    Albacete

  • Hospital Virgen de los lirios

    Alicante

  • Fundacio Hospital de L'Esperit Sant

    Barcelona

  • Hospital universitari Germans trias i Pujol

    Barcelona

  • Parc Santari Sant Joan de Deu - Hospital general

    Barcelona

  • Hospital general Universitario Santa Lucia

    Cartagena

  • Hospital general universitario de ciudad real

    Ciudad Real

  • Hospital Olot i Comarcal de ma Garrotxa

    Girona

  • Hospital universitari de Girona

    Girona

  • Hospital universitario Infanta Sofia

    Madrid

  • Hospital universitario Virgen del Rocio

    Seville

Other trials in Spain

Belgium7 sites

  • Erasmus Hospital Brussel

    Brussels

  • Institut Roi Albert II

    Brussels

  • AZ Groeninge

    Kortrijk

  • Uz Leuven

    Leuven

  • CHC Saint-Joseph

    Liège

  • CHR de la Citadelle

    Liège

  • CHU de Liège

    Liège

Other trials in Belgium

Netherlands7 sites

  • Amsterdam university medical center

    Amsterdam

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn

  • Rode Kruis Ziekenhuis

    Beverwijk

  • Albert Schweitzer Ziekenhuis

    Dordrecht

  • Tergooi Hospital Hilversum

    Hilversum

  • Leiden university medical center

    Leiden

  • Diakonessenhuis

    Utrecht

Other trials in Netherlands

Canada5 sites

  • University of Calgary

    Calgary, T2N 2T9

  • University of Alberta

    Edmonton, AB T6G 2R3

  • Ottawa Hospital Research Institute OTTAWA

    Ottawa, ON K1Y 4E9

  • Toronto General Hospital

    Toronto, M5G2C4

  • Diamond Health Care Centre

    Vancouver, BC V5Z 1M9

Other trials in Canada

Austria4 sites

  • Medical university of Graz

    Graz

  • Medical university of Innsbruck

    Innsbruck

  • Ordensklinikum Linz gmbH Elisabethinen

    Linz

  • Medical university of Vienna

    Vienna

Other trials in Austria

Greece4 sites

  • Athens School of Medicine

    Athens

  • National and Kapodistrian University of Athens ALEXANDRA Hospital

    Athens

  • University General Hospital "Attikon"

    Athens

  • University of Athens

    Athens

Other trials in Greece

Italy3 sites

  • Ospedale di Castelfranco Veneto

    Castelfranco Veneto

  • Opedale clinicizzato colle dell'ara

    Chieti

  • Universita di Perugia

    Perugia

Other trials in Italy

Switzerland3 sites

  • Istituto Oncologico della svizzera Italiana

    Bellinzona

  • Hopitaux universitaires de Genève

    Geneva

  • Lausanne university hospital - CHUV

    Lausanne

Other trials in Switzerland

Poland1 site

  • Centre of postgraduate medical education at the european health centre Otwock

    Otwock

Other trials in Poland

United Kingdom1 site

  • Queens centre castle hill hospital

    Cottingham

Other trials in United Kingdom

About this study

Official title: Long-term Treatment of Cancer Associated VTE: Reduced vs Full Dose of Apixaban : API-CAT STUDY for APIxaban Cancer Associated Thrombosis

The main objective is to determine whether a low-dose regimen of apixaban (2.5 mg bid) is non inferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent venous thromboembolism (VTE) in patients with active cancer who have completed at least 6 months of anticoagulant therapy for treating a documented index event of proximal deep venous thrombosis (DVT) (symptomatic or incidental) or pulmonary embolism (symptomatic or incidental).

Read the detailed description

For patients completing at least 6 months of anticoagulant therapy in whom the cancer is active, the thrombotic risk is arguably ongoing and indefinite anticoagulation seems required.

Given apixaban 5 mg bid is an alternative for the first 6 months of treatment, we intend to assess whether it is possible to lower the dose of apixaban (2.5 mg bid) after completing at least 6 months of anticoagulant treatment in a specific population of patients with cancer associated thrombosis (CAT) requiring extended anticoagulant treatment and with significant life expectancy. There are 2 conditions to be met : demonstrate the non-inferiority of the 2.5 mg bid regimen on the efficacy endpoint and then demonstrate the superiority of the 2.5 mg bid regimen as compared to the 5 mg bid on the safety endpoint.

It is a multicenter, international, prospective, randomized, parallel-group, double-blind non-inferiority trial with blinded adjudication of outcome events (approximately 160 centers in approximately 10 countries (France, Italy, Spain, Belgium, Greece, Netherlands, UK, Switzerland, Poland, Austria), with a number of expected inclusions of 11 patients per site.

Subjects should be randomized within 7 days after the last dose of their initial 6-month treatment, defined as the treatment ongoing after completing at least 6 months of anticoagulant treatment from the beginning of the anticoagulant treatment for the index event. This treatment may be low-molecular weight heparin (LMWH), direct oral anticoagulant (DOAC) or vitamin K antagonist (VKA). If a VKA was used as standard anticoagulant therapy, then an INR must be documented as 2 or less before randomization. Every attempt should be made to randomize subjects as soon as possible after the initial treatment has been discontinued.

Subjects will be stratified based on the cancer site and the type of disease treated (PE with/without DVT or DVT alone). If a subject had both symptomatic DVT and symptomatic PE, the subject will be stratified as having symptomatic PE.

Being tested
Apixaban 5 MG
Keywords
Cancer, VTE, Apixaban, Thrombosis
Medical subject headings
Neoplasms, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apixaban 5 MGDrug

    Also called Apixaban 2.5 MG

    Subjects will be randomized (1:1 ratio) to apixaban 5 mg bid (full dose) or apixaban 2.5 mg bid (reduced-dose) using a centralized IWRS (double blind study).

Study groups in NCT03692065
Study groupRoleWhat they receive
Apixaban film coated tablets 2.5 mgActive comparatorPatients randomized in the apixaban reduced dose group will receive an apixaban 2.5 mg tablet and a placebo of apixaban 5 mg tablet, twice daily for 12 months.
Receives: Drug: Apixaban 5 MG
Apixaban film coated tablets 5 mgActive comparatorPatients randomized in the apixaban full dose group will receive a placebo of apixaban 2.5 mg tablet and an apixaban 5 mg tablet, twice daily for 12 months.
Receives: Drug: Apixaban 5 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of an an adjudicated composite endpoint

    The incidence of an adjudicated composite of recurrent symptomatic VTE (proximal and/or distal DVT and/or symptomatic PE and/or upper limb or central venous catheter thrombosis or incidental VTE (proximal DVT or PE), or death due to PE during the treatment period.

    Incidental VTE is defined as proximal DVT or PE detected by imaging incidentally when a patient undergoes imaging studies as standard of care for the management of the malignancy or other reasons but not for a VTE suspicion.

    Measured: During the treatment period (12 months)

Secondary outcomes (6)

  1. The incidence of adjudicated major and clinically relevant non-major bleeding

    The definition of major bleeding described is adapted from the International Society on Thrombosis and Hemostasis (ISTH) definition (Schulman JTH 2005).

    Measured: During the treatment period (12 months)

  2. Recurrent symptomatic VTE

    Recurrent VTE objectively confirmed after clinical suspicion

    Measured: During the treatment period (12 months)

  3. VTE related-death

    VTE related-death: PE based on objective diagnostic testing, autopsy, or sudden death; i.e. death occurring within one hour of the onset of new symptoms which cannot be attributed to a documented cause (unexplained death) and for which PE/DVT cannot be ruled out as the cause.

    Measured: During the treatment period (12 months)

  4. All-cause death

    All deaths will be adjudicated by the ICAC and classified as either VTE-related, cancer death (including all deaths due to the underlying cancer), bleeding-related or others, including all deaths due to a clearly documented other cause, such as respiratory failure (e.g., terminal emphysema), infections/sepsis etc.

    Measured: During the treatment period (12 months)

  5. Adjudicated major bleeding.

    The definition of major bleeding described is adapted from the International Society on Thrombosis and Hemostasis (ISTH) definition (Schulman 2005) and includes

    • Acute clinically overt bleeding with one or more of the following:
    • A decrease in hemoglobin (Hgb) of 2 g/dL or more
    • A transfusion of 2 or more units of packed red blood cells
    • Symptomatic bleeding that occurs in at least one of the following critical sites:
    • Intracranial
    • Intraspinal
    • Intraocular (within the corpus of the eye; thus, a conjunctival bleed is not an intraocular bleed)
    • Pericardial
    • Intra-articular
    • Intramuscular with compartment syndrome
    • Retroperitoneal
    • Bleeding that is fatal: bleeding event that the independent adjudication committee determines is the primary cause of death or contributes directly to death.

    Measured: During the treatment period (12 months)

  6. Adjudicated composite of recurrent symptomatic VTE, VTE related-death, all-cause death, adjudicated major bleeding.

    Adjudicated composite of recurrent symptomatic VTE, VTE related-death, all-cause death, adjudicated major bleeding.

    Measured: During the treatment period (12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2018
  2. Study start11 Oct 2018
  3. Primary completion6 Sep 2024
  4. Study completion20 Oct 2024

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03692065
Sponsor's protocol ID
P170604J
Acronym
API-CAT
Status last verified
Feb 2025
First submitted
28 Sep 2018
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mahe I, Happe F, Monreal M, Robert-Ebadi H, Debourdeau P, Fabreguettes JR, Accassat S, Mismetti P, Girard P, Laporte S, Chapelle C. API-CAT investigators' decisions on anticoagulation following extended treatment for cancer-associated thrombosis. Eur Heart J Cardiovasc Pharmacother. 2026 Sep 22;12(6):447-457. doi: 10.1093/ehjcvp/pvag046.

    PubMed 42361291

  • Mahe I, Chapelle C, Girard P, Carrier M, Palomares LJ, Samama CM, Helfer H, Gerotziafas G, Laporte S, Vicaut E, Mismetti P; API-CAT Study Group; API-CAT Investigators. Predictors of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (API-CAT): a post-hoc analysis of a randomised, non-inferiority trial. Lancet Haematol. 2026 Jan;13(1):e41-e48. doi: 10.1016/S2352-3026(25)00291-1. Epub 2025 Dec 6.

    PubMed 41365312

  • Mahe I, Carrier M, Mayeur D, Chidiac J, Vicaut E, Falvo N, Sanchez O, Grange C, Monreal M, Lopez-Nunez JJ, Otero-Candelera R, Le Gal G, Yeo E, Righini M, Robert-Ebadi H, Huisman MV, Klok FA, Westerweel P, Agnelli G, Becattini C, Bamias A, Syrigos K, Szmit S, Torbicki A, Verhamme P, Maraveyas A, Cohen AT, Ay C, Chapelle C, Meyer G, Couturaud F, Mismetti P, Girard P, Bertoletti L, Laporte S; API-CAT Investigators. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Apr 10;392(14):1363-1373. doi: 10.1056/NEJMoa2416112. Epub 2025 Mar 29.

    PubMed 40162636

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Apixaban 5 MG in people with Cancer-associated Thrombosis, run by Assistance Publique - Hôpitaux de Paris at 114 sites in 11 countries.

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 14 inclusion and 35 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 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in France, Spain, Belgium, Netherlands, Canada and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of an an adjudicated composite endpoint (time frame: During the treatment period (12 months)). 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 NCT03692065, which also lists 3 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 6 Feb 2025.

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