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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05485961




Registration number
NCT05485961
Ethics application status
Date submitted
29/07/2022
Date registered
3/08/2022
Date last updated
11/05/2025

Titles & IDs
Public title
Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis
Scientific title
A Phase 2b / 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Combined Dose-Finding and Cardiovascular Outcome Study to Investigate the Efficacy and Safety of CSL300 (Clazakizumab) in Subjects With End Stage Kidney Disease Undergoing Dialysis
Secondary ID [1] 0 0
2022-500273-14-00
Secondary ID [2] 0 0
CSL300_2301
Universal Trial Number (UTN)
Trial acronym
POSIBIL6ESKD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
End Stage Kidney Disease 0 0
Atherosclerotic Cardiovascular Disease in Patients With ESKD 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CSL300
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: CSL300 (low dose)(Phase 2b) - Intravenous (IV) administration

Experimental: CSL300 (medium dose)(Phase 2b) - IV administration

Experimental: CSL300 (high dose)(Phase 2b) - IV administration

Placebo comparator: Placebo (Phase 2b) - IV administration

Experimental: CSL300 (Phase 3) - IV administration

Placebo comparator: Placebo (Phase 3) - IV administration


Treatment: Drugs: CSL300
IV administration

Treatment: Drugs: Placebo
0.9% w/v NaCl

Treatment: Drugs: Placebo
Matching the excipient content and concentration of the CSL300 product, minus the active ingredient.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline on the log scale in high-sensitivity C-reactive protein (hs-CRP)(Phase 2b)
Timepoint [1] 0 0
Baseline and up to 12 weeks
Primary outcome [2] 0 0
Time to first occurrence of CV death or myocardial infarction (MI) (Phase 3)
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
Percent of participants achieving hs-CRP less than (<) 2.0 milligram per Liter (mg/L) (Phase 2b)
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Change from baseline in log-transformed hs-CRP (Phase 2b)
Timepoint [2] 0 0
Baseline and up to 24 weeks
Secondary outcome [3] 0 0
Mean change from Baseline in serum amyloid A (SAA) (Phase 2b)
Timepoint [3] 0 0
Baseline and up to 12 weeks
Secondary outcome [4] 0 0
Mean change from Baseline in secretory phospholipase A2 (sPLA2) (Phase 2b)
Timepoint [4] 0 0
Baseline and up to 12 weeks
Secondary outcome [5] 0 0
Mean change from Baseline in fibrinogen (Phase 2b)
Timepoint [5] 0 0
Baseline and up to 12 weeks
Secondary outcome [6] 0 0
Mean change from Baseline in plasminogen activator inhibitor -1 (PAI-1) (Phase 2b)
Timepoint [6] 0 0
Baseline and up to 12 weeks
Secondary outcome [7] 0 0
Mean change from Baseline in lipoprotein (Lp) (a) (Phase 2b)
Timepoint [7] 0 0
Baseline and up to 12 weeks
Secondary outcome [8] 0 0
Mean change from Baseline in albumin (Phase 2b)
Timepoint [8] 0 0
Baseline and up to 12 weeks
Secondary outcome [9] 0 0
Mean change from Baseline in Hepcidin (Phase 2b)
Timepoint [9] 0 0
Baseline and up to 12 weeks
Secondary outcome [10] 0 0
Mean change from Baseline in hemoglobin (Phase 2b)
Timepoint [10] 0 0
Baseline and up to 12 weeks
Secondary outcome [11] 0 0
Mean change from Baseline in erythropoiesis-stimulating agents (ESA) (Phase 2b)
Timepoint [11] 0 0
Baseline and up to 12 weeks
Secondary outcome [12] 0 0
Mean change from Baseline in erythropoietin-resistance index (ERI) (Phase 2b)
Timepoint [12] 0 0
Baseline and up to 12 weeks
Secondary outcome [13] 0 0
Mean change from Baseline in iron (Phase 2b)
Timepoint [13] 0 0
Baseline and up to 12 weeks
Secondary outcome [14] 0 0
Mean change from Baseline in total iron binding capacity (TIBC) (Phase 2b)
Timepoint [14] 0 0
Baseline and up to 12 weeks
Secondary outcome [15] 0 0
Mean change from Baseline in transferrin saturation (TSAT) (Phase 2b)
Timepoint [15] 0 0
Baseline and up to 12 weeks
Secondary outcome [16] 0 0
Mean change from Baseline in ferritin (Phase 2b)
Timepoint [16] 0 0
Baseline and up to 12 weeks
Secondary outcome [17] 0 0
Area under the plasma concentration versus time curve (AUC) for CSL300 (Phase 2b)
Timepoint [17] 0 0
Up to 24 weeks
Secondary outcome [18] 0 0
Peak Plasma Concentration (Cmax) for CSL300 (Phase 2b)
Timepoint [18] 0 0
Up to 24 weeks
Secondary outcome [19] 0 0
Trough Plasma Concentration (Ctrough) for CSL300 (Phase 2b)
Timepoint [19] 0 0
Up to 24 weeks
Secondary outcome [20] 0 0
Time to Maximum Plasma Concentration (Tmax) for CSL300 (Phase 2b)
Timepoint [20] 0 0
Up to 24 weeks
Secondary outcome [21] 0 0
Percent of participants with adverse events (AE), serious AE (SAE), including adverse events of special interest (AESIs) (Phase 2b)
Timepoint [21] 0 0
Up to 32 weeks
Secondary outcome [22] 0 0
Mean change from Baseline in white blood cell (WBC) (Phase 2b)
Timepoint [22] 0 0
Up to 12 weeks
Secondary outcome [23] 0 0
Mean change from Baseline in neutrophils (Phase 2b)
Timepoint [23] 0 0
Up to 12 weeks
Secondary outcome [24] 0 0
Mean change from Baseline in platelets (Phase 2b)
Timepoint [24] 0 0
Up to 12 weeks
Secondary outcome [25] 0 0
Mean change from Baseline in aspartate aminotransferase (AST) (Phase 2b)
Timepoint [25] 0 0
Up to 12 weeks
Secondary outcome [26] 0 0
Mean change from Baseline in alanine aminotransferase (ALT) (Phase 2b)
Timepoint [26] 0 0
Up to 12 weeks
Secondary outcome [27] 0 0
Mean change from Baseline in total bilirubin (Phase 2b)
Timepoint [27] 0 0
Up to 12 weeks
Secondary outcome [28] 0 0
Mean change from Baseline in lipid panel (Phase 2b)
Timepoint [28] 0 0
Up to 12 weeks
Secondary outcome [29] 0 0
Titer of confirmed antibodies specific to CSL300 (Phase 2b)
Timepoint [29] 0 0
Up to 12 weeks
Secondary outcome [30] 0 0
Time to first occurrence of all-cause death or MI (Phase 3)
Timepoint [30] 0 0
Approximately 5 years
Secondary outcome [31] 0 0
Time to first occurrence of CV death, MI, or ischemic stroke (Phase 3)
Timepoint [31] 0 0
Approximately 5 years
Secondary outcome [32] 0 0
Time to first occurrence of CV death (Phase 3)
Timepoint [32] 0 0
Approximately 5 years
Secondary outcome [33] 0 0
Time to first occurrence of CV death, MI or major adverse limb event (Phase 3)
Timepoint [33] 0 0
Approximately 5 years
Secondary outcome [34] 0 0
Time to first occurrence of all-cause death (Phase 3)
Timepoint [34] 0 0
Approximately 5 years
Secondary outcome [35] 0 0
Time to first occurrence of CV death, MI, or hospitalization for heart failure (HF) (Phase 3)
Timepoint [35] 0 0
Approximately 5 years
Secondary outcome [36] 0 0
Total number of CV hospitalizations (Phase 3)
Timepoint [36] 0 0
Approximately 5 years
Secondary outcome [37] 0 0
Total number of HF hospitalizations and urgent visits (Phase 3)
Timepoint [37] 0 0
Approximately 5 years
Secondary outcome [38] 0 0
Total number of hospitalizations (Phase 3)
Timepoint [38] 0 0
Approximately 5 years

Eligibility
Key inclusion criteria
* Male or female at least 18 years of age
* A diagnosis of ESKD undergoing maintenance dialysis for at least 12 weeks
* Serum hs-CRP = 2.0 mg/L
* A diagnosis of diabetes mellitus OR ASCVD
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects who participated in Part 1 (phase 2b) are not eligible to participate in Part 2 (phase 3)
* Concomitant use of systemic immunosuppressant drugs
* Abnormal LFTs
* Any life-threatening disease expected to result in death within 12 months
* A history of GI perforation, inflammatory bowel disease (except fully excised ulcerative colitis), or peptic ulcer disease
* Clinically significant active infection or history of opportunistic or invasive fungal infection

Study design
Purpose of the study
Other
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2029
Actual
Sample size
Target
2310
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
03600023 - Royal North Shore Hospital (RNSH) - Saint Leonards
Recruitment hospital [2] 0 0
03600017 - Concord Repatriation General Hospital - Sydney
Recruitment hospital [3] 0 0
03600037 - Cairns Hospital - Cairns
Recruitment hospital [4] 0 0
03600021 - Sunshine Coast University Private Hospital - Nambour
Recruitment hospital [5] 0 0
03600014 - Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [6] 0 0
03600013 - Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
03600011 - Sunshine Hospital - St Albans
Recruitment hospital [8] 0 0
03600050 - Fiona Stanley Hospital - Murdoch
Recruitment hospital [9] 0 0
03600020 - Gold Coast University Hospital - Southport
Recruitment hospital [10] 0 0
03600012 - Westmead Hospital - Westmead
Recruitment hospital [11] 0 0
03600048 - Wollongong Renal Unit - Wollongong
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [2] 0 0
2139 - Sydney
Recruitment postcode(s) [3] 0 0
4870 - Cairns
Recruitment postcode(s) [4] 0 0
4560 - Nambour
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3021 - St Albans
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment postcode(s) [9] 0 0
4215 - Southport
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
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Mississippi
Country [17] 0 0
United States of America
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Missouri
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United States of America
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Nebraska
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United States of America
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Nevada
Country [20] 0 0
United States of America
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New Hampshire
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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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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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
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West Virginia
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Belgium
State/province [31] 0 0
Aalst
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Belgium
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Bonheiden
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Belgium
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Gent
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Belgium
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La Louvière
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Belgium
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Leuven
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Belgium
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Liège
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Belgium
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Roeselare
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Bulgaria
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Lom
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Bulgaria
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Smolyan
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Quebec
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Montréal
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Toronto
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China
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Beijing
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China
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Zhenjiang City
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Aalborg
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Herlev
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Montpellier
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Paris
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Saint-Ouen
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Strasbourg
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France
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Toulouse
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Germany
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Berlin
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Germany
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Hessen
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Germany
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Kaiserslautern
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Germany
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Kiel
Country [67] 0 0
Germany
State/province [67] 0 0
Mainz
Country [68] 0 0
Germany
State/province [68] 0 0
Villingen-Schwenningen
Country [69] 0 0
Greece
State/province [69] 0 0
Alexandroupolis
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Greece
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Crete
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Greece
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Ioánnina
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Greece
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Larissa
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Greece
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Rio
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Greece
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Thessaloniki
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Greece
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Thessaloníki
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Greece
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Árta
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Hungary
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Kistarcsa
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Israel
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Haifa
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Israel
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H_olon
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Tiberias
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Israel
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Zefat
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Italy
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Brescia
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Italy
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Caserta
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Italy
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Florence
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Italy
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Foggia
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Italy
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Lecco
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Italy
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Messina
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Italy
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Milano
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Italy
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Novara
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Italy
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Pavia
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Italy
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Peschiera Del Garda
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Italy
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Prato
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Italy
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Rimini
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Italy
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San Giovanni Rotondo
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Italy
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Verona
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Japan
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Aichi
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Japan
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Chiba-ken
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Japan
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Fukuoka
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Shiga
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Japan
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Tokyo
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Japan
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Hashima-gun
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Higashiosaka-shi
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Japan
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Inashiki-gun
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Japan
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Kagoshima-shi
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Japan
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Kurume-shi
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Japan
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Kurume
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Japan
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Kyoto-Shi
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Japan
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Nagaoka-Shi
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Japan
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Nagoya-shi
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Japan
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Nagoya
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Japan
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Omihachiman
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Japan
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Oyama-shi
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Japan
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Sakaimachi
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Japan
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Takasaki-Shi
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Japan
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Tsukuba-shi
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Japan
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Ube-shi
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Japan
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Yokohama-shi
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Japan
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Yonago-shi
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Korea, Republic of
State/province [124] 0 0
Seoul
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Korea, Republic of
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Anyang-si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gangnam-gu
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Korea, Republic of
State/province [128] 0 0
Goyang-si
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Gwangju
Country [130] 0 0
Korea, Republic of
State/province [130] 0 0
Wonju-si
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Portugal
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Braga
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Portugal
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Loures
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Portugal
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Oeiras
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Portugal
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Porto
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Romania
State/province [135] 0 0
Bucharest
Country [136] 0 0
Romania
State/province [136] 0 0
Bucuresti
Country [137] 0 0
Romania
State/province [137] 0 0
Constanta
Country [138] 0 0
Romania
State/province [138] 0 0
Satu Mare
Country [139] 0 0
Spain
State/province [139] 0 0
Lleida
Country [140] 0 0
Sweden
State/province [140] 0 0
Uppsala
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United Kingdom
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Bradford
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United Kingdom
State/province [142] 0 0
Coventry
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Derby
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Liverpool
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Londonderry
Country [146] 0 0
United Kingdom
State/province [146] 0 0
London
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Salford
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Stoke-on-Trent
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Wolverhampton

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Registration Coordinator
Address 0 0
Country 0 0
Phone 0 0
+1 610-878-4697
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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/NCT05485961