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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05926349




Registration number
NCT05926349
Ethics application status
Date submitted
9/06/2023
Date registered
3/07/2023

Titles & IDs
Public title
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
Scientific title
A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)
Secondary ID [1] 0 0
D9604C00001
Universal Trial Number (UTN)
Trial acronym
ANNEXA-RS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urgent Surgery 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Andexanet alfa
Treatment: Drugs - Usual Care

Experimental: Andexanet Alfa Group - Patients will receive andexanet alfa as IV bolus followed by an infusion.

Active comparator: Usual Care Group - Patients will receive treatment based on the Investigator's discretion, according to regional, local/institutional guidelines or practices.


Treatment: Drugs: Andexanet alfa
Andexanet is a recombinant version of human FXa

Treatment: Drugs: Usual Care
As per the label of the chosen usual care product(s) and/or usual care standards.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of patients achieving effective intraoperative hemostasis
Timepoint [1] 0 0
From start to the end of surgery or procedure on Day 0
Secondary outcome [1] 0 0
Change from Baseline in anti-FXa activity measured through blood samples
Timepoint [1] 0 0
Baseline to start of surgery or procedure
Secondary outcome [2] 0 0
Change from Baseline in anti-FXa activity measured through blood samples
Timepoint [2] 0 0
Baseline to two hours post start of surgery or procedure

Eligibility
Key inclusion criteria
* The patient requires, in the opinion of the Investigator, urgent surgery or procedure and requires reversal of direct oral FXa inhibition.
* The patient requires urgent surgery or procedure within 12 hours of informed consent.
* The patient requires urgent surgery or procedure that is expected to be associated with a high risk of bleeding or bleeding to occur into a critical organ.
* The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more, prior to start of surgery or procedure.
* Female patients of childbearing potential must have a negative pregnancy test at Screening.
* Willingness to use highly effective methods of contraception (for male and female patients who are fertile).
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The patient requires surgeries or procedures that have a very low chance of causing significant, uncontrollable bleeding, such as small skin procedures, cataract surgery, and minor dental procedures.
* The patient has acute life-threatening bleeding at the time of Screening.
* The patient will undergo a surgery or procedure which will require the use of heparin.
* Patient who is not expected to live for more than three months due to other health problems or has specifically requested not to be resuscitated if their heart stops beating.
* Prior to screening, the patient had either experienced low platelet count due to heparin use with or without blood clots or had a genetic condition that affects blood clotting.
* Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septic shock at the time of Screening.
* Patient has history of heparin-induced thrombocytopenia (with or without thrombosis) or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at the time of Screening.
* Previously diagnosed with a bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
* Prior known hypersensitivity to andexanet alfa.
* Use of andexanet alfa 30 days prior to Screening.
* Patient diagnosed with dementia.
* Any prohibited medication as determined in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
20/10/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/11/2026
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Epping
Recruitment hospital [4] 0 0
Research Site - Fitzroy
Recruitment hospital [5] 0 0
Research Site - Garran
Recruitment hospital [6] 0 0
Research Site - Melbourne
Recruitment hospital [7] 0 0
Research Site - New Lambton Heights
Recruitment hospital [8] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
3076 - Epping
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
2605 - Garran
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [8] 0 0
NSW 2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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Colorado
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Tennessee
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Argentina
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Buenos Aires
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Argentina
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Córdoba
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Argentina
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Mar del Plata
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Argentina
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Quilmes
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Austria
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Graz
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Belgium
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Aalst
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Belgium
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Ghent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Brazil
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Florianopolis
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Brazil
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Ribeirão Preto
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Bulgaria
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Lom
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Canada
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Quebec
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China
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Beijing
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China
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Haerbin
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China
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Hangzhou
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China
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Wuhan
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Czechia
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Brno
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Czechia
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Prague
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Czechia
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Praha 10
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Czechia
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Usti nad Labem
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Denmark
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København NV
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Estonia
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Tallinn
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Finland
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Helsinki
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Finland
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Tampere
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France
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Nantes cedex 1
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France
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Nimes
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Georgia
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Tbilisi
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Germany
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Aachen
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Germany
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Dresden
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Germany
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Lübeck
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Germany
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Mainz
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Germany
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Murnau
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Germany
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Rostock
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Pécs
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Hungary
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Székesfehérvár
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Hungary
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Zalaegerszeg
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Israel
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Ashdod
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel-Aviv
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Italy
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Alessandria
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Italy
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Catania
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Italy
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Milano
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Italy
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Parma
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Italy
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Pisa
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Italy
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Roma
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Italy
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Varese
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Japan
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Bunkyo-ku
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Japan
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Hiroshima-shi
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Japan
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Kashihara-shi
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Japan
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Kawasaki-shi
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Japan
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Kumamoto-shi
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Japan
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Kurume
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Japan
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Sakai-shi
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Japan
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Sendai-shi
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Korea, Republic of
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Daegu
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Malaysia
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Kuala Lumpur
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Malaysia
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Kuantan
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Mexico
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Aguascalientes
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Mexico
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Nuevo Leon
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Mexico
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San Luis Río Colorado
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New Zealand
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Auckland
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Szczecin
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Poland
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Lódz
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Portugal
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Amadora
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Portugal
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Lisboa
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Portugal
State/province [84] 0 0
Porto
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Romania
State/province [85] 0 0
Bucuresti
Country [86] 0 0
Romania
State/province [86] 0 0
Timisoara
Country [87] 0 0
Serbia
State/province [87] 0 0
Kragujevac
Country [88] 0 0
Serbia
State/province [88] 0 0
Nis
Country [89] 0 0
Serbia
State/province [89] 0 0
Novi Sad
Country [90] 0 0
Serbia
State/province [90] 0 0
Sremska Kamenica
Country [91] 0 0
Singapore
State/province [91] 0 0
Singapore
Country [92] 0 0
Slovakia
State/province [92] 0 0
Bratislava
Country [93] 0 0
Slovenia
State/province [93] 0 0
Celje
Country [94] 0 0
Spain
State/province [94] 0 0
Barcelona
Country [95] 0 0
Spain
State/province [95] 0 0
Elche
Country [96] 0 0
Spain
State/province [96] 0 0
L'Hospitalet de Llobregat
Country [97] 0 0
Spain
State/province [97] 0 0
Madrid
Country [98] 0 0
Spain
State/province [98] 0 0
Marbella (Málaga)
Country [99] 0 0
Spain
State/province [99] 0 0
Sevilla
Country [100] 0 0
Spain
State/province [100] 0 0
Valencia
Country [101] 0 0
Switzerland
State/province [101] 0 0
Zurich
Country [102] 0 0
Taiwan
State/province [102] 0 0
Tainan
Country [103] 0 0
United Kingdom
State/province [103] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05926349