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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02586233




Registration number
NCT02586233
Ethics application status
Date submitted
21/10/2015
Date registered
26/10/2015

Titles & IDs
Public title
Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
Scientific title
A Phase 1b/2, Multi-Center, Double-Blind (Principal Investigators and Study Subjects Blinded, Sponsor Unblinded), Placebo-Controlled, Randomized, Single-Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of DS-1040b in Subjects With Acute Ischemic Stroke
Secondary ID [1] 0 0
2015-001824-43
Secondary ID [2] 0 0
DS1040-A-U103
Universal Trial Number (UTN)
Trial acronym
ASSENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Thrombotic Disease 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
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 - DS-1040b
Treatment: Drugs - Placebo

Experimental: DS-1040b - Participants who will be randomized to receive intravenous (IV) infusion of DS-1040b ranging from 0.6 mg to 9.6 mg.

Placebo comparator: Placebo - Participants who will be randomized to receive intravenous (IV) infusion of placebo.


Treatment: Drugs: DS-1040b
DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period

Treatment: Drugs: Placebo
0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summary of Treatment-Emergent Adverse Event Reported by >10% of Participants Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Timepoint [1] 0 0
Baseline up to 90 days post last dose, up to 3 years 11 months
Secondary outcome [1] 0 0
Summary of Pharmacokinetic (PK) Parameter Maximum (Peak) Observed Plasma Concentration (Cmax) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Timepoint [1] 0 0
Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Secondary outcome [2] 0 0
Summary of Pharmacokinetic Parameter Area Under the Concentration Versus Time Curve From Zero to Last Quantifiable Concentration Sampling Point (AUClast) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Timepoint [2] 0 0
Predose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours postdose
Secondary outcome [3] 0 0
Summary of Pharmacokinetic Parameter Terminal Half-life (t1/2) of DS-1040b Following Ascending Doses in Participants With Acute Ischemic Stroke
Timepoint [3] 0 0
Pre-dose, 0.5, 3, 6, 9, 12, 24, 48, 72, and 96 hours post-dose
Secondary outcome [4] 0 0
Summary of Activated Form of Thrombin-activatable Fibrinolysis Inhibitor (TAFIa) Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Timepoint [4] 0 0
Baseline and 6 hours postdose
Secondary outcome [5] 0 0
Summary of Changes From Baseline at Day 30 in National Institute of Health Stroke Scale (NIHSS) Score Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Timepoint [5] 0 0
30 days post dose
Secondary outcome [6] 0 0
Percentage of Participants With a Modified Rankin Scale (mRS) Score of 0 to 2 Following Ascending Doses of DS-1040b and a Placebo in Participants With Acute Ischemic Stroke
Timepoint [6] 0 0
Day 5 (baseline) and Day 90 post dose

Eligibility
Key inclusion criteria
* Has a clinical diagnosis of acute ischemic stroke (including lacunar stroke/infarct) supported by computed topography or magnetic resonance imaging to rule out alternative cause for presenting symptoms
* Has onset of stroke symptoms within 4.5 to 12 hours before initiation of study drug administration - for subjects with a stroke upon waking, time of symptom onset is the last time the subject was known to be well
* Has a NIHSS score of = 2 (for Cohorts 1-5) and = 5 (for Cohort 6)
* Has Low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment start completion and after confirmation of no intracranial bleeding on the 24-hours repeat brain imaging.
* Is a Cohort 6 participant who is treated or anticipated to be treated with intra-arterial therapy (IAT) for ischemic stroke at the time of randomization (for enrollment in the IAT subgroup)
* Has given written informed consent to participate in the study prior to participating in any study-related procedures - depending on country-specific practice, written informed consent may be acceptable from legally authorized representative
* Has given a separate written informed consent for collecting a blood sample for genotyping
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is a Cohort 1-5 participant who has been treated or is going to be treated with tissue plasminogen activator (tPA) and/or endovascular thrombectomy during current stroke
* Is a Cohort 6 participant treated or anticipated to be treated with tPA during current stroke
* Has evidence of intracranial hemorrhage on non-contrast computed tomography (CT/CAT) scan or magnetic resonance imaging (MRI)
* Has symptoms of subarachnoid hemorrhage, even with normal imaging
* Has an Alberta Stroke Program Early CT Score (ASPECTS) <6
* Has prior non-traumatic intracranial hemorrhage (excluding microhemorrhages observed in imaging)
* Has known arteriovenous malformation or aneurysm
* Has evidence of active bleeding
* Has platelet count less than 100,000
* Has International Normalized Ratio greater than 1.7
* Has used unfractionated heparin within 24 hours prior to treatment and has an elevated partial thromboplastin time
* Has used a non-vitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 24 hours before treatment
* Has used fondaparinux or low molecular weight heparin at an anticoagulation dose within 24 hours prior to treatment
* Has anticipated use of an anticoagulation dose of heparin, or fondaparinux or low molecular weight heparin, or nonvitamin K antagonist oral anticoagulant such as dabigatran, rivaroxaban, apixaban, or other factor Xa inhibitors within 48 hours after completion of study drug treatment (low dose heparin or low molecular weight heparin at a preventive dose are allowed from 24 hours after treatment completion and after confirmation of no intracranial bleeding on the 24 hours repeat brain imaging. In Cohort 6, heparin treatment associated with IAT is allowed.)
* Has blood pressure > 185/110 mmHg, or requires aggressive medication to maintain blood pressure below this limit (routine medical treatment including IV drug treatment is allowed to lower the blood pressure below this limit)
* Has had intracranial surgery, clinically significant head trauma (in the opinion of Principal Investigator), Alteplase treatment, or a previous stroke within 1 month
* Has had major surgery within 14 days
* Has had gastrointestinal or genitourinary bleeding in the last 21 days
* Has had a lumbar puncture (or epidural steroid injection) within 14 days
* Has had a preexisting disability classified by modified Rankin Scale (mRS) > 2
* Has an estimated glomerular filtration rate < 60 mL/min/1.73 m^2
* Has baseline hemoglobin < 10.5 g/dL
* Has a positive pregnancy test
* Is currently participating in another investigational study or has participated in an investigational drug study within 30 days or 5 half-lives of that investigational drug prior to administration of the study drug
* Is an employee or an immediate family member of an employee of the Sponsor, the Contract Research Organization (CRO), or the Site
* Has any other condition the investigator determines would preclude participation 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/08/2019
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital Neurology Dept. - Adelaide
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3050 - Parkville
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Czechia
State/province [16] 0 0
Brno
Country [17] 0 0
Czechia
State/province [17] 0 0
Ostrava Vitkovice
Country [18] 0 0
France
State/province [18] 0 0
Besançon
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
France
State/province [20] 0 0
Lille
Country [21] 0 0
Germany
State/province [21] 0 0
Altenburg
Country [22] 0 0
Germany
State/province [22] 0 0
Essen
Country [23] 0 0
Germany
State/province [23] 0 0
Frankfurt am Main
Country [24] 0 0
Italy
State/province [24] 0 0
Città di Castello
Country [25] 0 0
Italy
State/province [25] 0 0
Gubbio
Country [26] 0 0
Italy
State/province [26] 0 0
Piacenza
Country [27] 0 0
Italy
State/province [27] 0 0
Pietra Ligure
Country [28] 0 0
Italy
State/province [28] 0 0
Pisa
Country [29] 0 0
Italy
State/province [29] 0 0
Verona
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Busan
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Seongnam-si
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Seoul
Country [33] 0 0
Slovakia
State/province [33] 0 0
Rimavská Sobota
Country [34] 0 0
Slovakia
State/province [34] 0 0
Spišská Nová Ves
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Santiago de Compostela
Country [38] 0 0
Spain
State/province [38] 0 0
Sevilla
Country [39] 0 0
Spain
State/province [39] 0 0
Valladolid
Country [40] 0 0
Spain
State/province [40] 0 0
Zaragoza
Country [41] 0 0
Taiwan
State/province [41] 0 0
Hsien
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Taipei
Country [45] 0 0
United Kingdom
State/province [45] 0 0
England
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Scotland
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Salford
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Stoke-on-Trent

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

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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?
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Available to whom?
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02586233