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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04680026
Registration number
NCT04680026
Ethics application status
Date submitted
17/12/2020
Date registered
22/12/2020
Titles & IDs
Public title
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
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Scientific title
A Phase 2, Two-Stage, Serial Cohort Dose Escalation and Expansion Study of a Single Intravenous Infusion of HBI 3000 for the Conversion of Atrial Fibrillation (AF) of Recent Onset
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Secondary ID [1]
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HBI-3000-402
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - HBI-3000
Treatment: Drugs - Placebo
Experimental: Drug: HBI-3000, Stage A Dose Level 1 - Stage A Open Label HBI-3000 Dose Level 1: 200 mg
Experimental: Drug: HBI-3000, Stage A Dose Level 2 - Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned
Experimental: Drug: HBI-3000, Stage A Dose Level 3 - Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned
Experimental: Drug: HBI-3000, Stage B Dose Level 1 - Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results
Experimental: Drug: HBI-3000, Stage B Dose Level 2 - Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results
Treatment: Drugs: HBI-3000
Small molecule, multi-ion channel blocker
Treatment: Drugs: Placebo
Normal saline
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)
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Assessment method [1]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by the incidence of adverse events (AEs)
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Timepoint [1]
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30 days
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Primary outcome [2]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)
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Assessment method [2]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in heart rate (HR) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically:
HR \< 40 bpm for 2 minutes or longer within 90 minutes of initiation of the infusion
HR increase \> 25 percent before conversion to SR (based on one minute averages compared between the event and the first minute of stable telemetry)
HR \> 120 bpm for one minute or longer after conversion to SR and within 90 minutes of initiation of the infusion
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Timepoint [2]
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90 minutes
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Primary outcome [3]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)
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Assessment method [3]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in blood pressure (BP) from baseline (prior to Study Drug infusion) to study timepoints during and after Study Drug infusion, specifically: Systolic BP \< 90 mmHg for \> 1 minute during SR and within 90 minutes of initiation of the infusion
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Timepoint [3]
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90 minutes
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Primary outcome [4]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level
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Assessment method [4]
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Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes from baseline (prior to Study Drug infusion) to 24 hour post-infusion, specifically:
QTcF: \> 500 msec and \> 60 msec above the 24-hour post-conversion level during SR
PR: \> 50 percent above the 24-hour post-conversion level during SR
QRS: = 33 percent above the 24-hour post-conversion level during SR
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Timepoint [4]
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24 hours
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Primary outcome [5]
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The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
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Assessment method [5]
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Evaluate the efficacy of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset as measured by the proportion of patients with AF of recent onset who convert to SR (for a duration of at least one minute) within 120 minutes of the start of infusion
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Timepoint [5]
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120 minutes
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Secondary outcome [1]
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Evaluate the time to conversion to SR from start of infusion
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Assessment method [1]
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Efficacy as measured by the time from the start of infusion to the time of conversion to SR for a duration of at least one minute
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Timepoint [1]
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24 hours
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Secondary outcome [2]
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Evaluate the proportion of patients with sustained AF or late conversion to SR
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Assessment method [2]
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Efficacy as measured by the proportion of patients with sustained or late conversion of AF of recent onset to SR at 12 hours, 24 hours and 7 days after start of infusion
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Timepoint [2]
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12 hours, 24 hours and 7 days
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Eligibility
Key inclusion criteria
* 18 to 80 years of age
* Sustained AF of > 2 hours and < 72 hours duration
* Eligible for cardioversion (electrical and pharmacologic)
* On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing
* Hemodynamic instability that may require emergency electrical cardioversion
* Atrial flutter
* Moderate to severe HF
* Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity
* Known or suspected hyperthyroidism
* Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months
* Presence of LA thrombus by TEE or TTE
* Presence of concurrent myocarditis or endocarditis
* ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns
* Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC)
* Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before enrollment)
* Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration
* Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure
* Clinically significant laboratory abnormalities
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Illinois
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Country [3]
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United States of America
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State/province [3]
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Kentucky
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Country [4]
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United States of America
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State/province [4]
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Mississippi
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Country [5]
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United States of America
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State/province [5]
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Oklahoma
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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Bosnia and Herzegovina
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State/province [7]
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Banja Luka
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Country [8]
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Bosnia and Herzegovina
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State/province [8]
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Tuzla
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Country [9]
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Canada
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State/province [9]
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Quebec
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Country [10]
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New Zealand
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State/province [10]
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Hamilton
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Country [11]
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New Zealand
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State/province [11]
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Wellington
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Country [12]
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Serbia
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State/province [12]
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Bulevar Doktora
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Country [13]
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Serbia
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State/province [13]
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Belgrade
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
HUYABIO International, LLC.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This Phase 2 study is a two-stage, serial cohort dose escalation and expansion study of a single 30-minute (IV) infusion of HBI-3000 for the conversion of patients with recent-onset atrial fibrillation (AF). Stage A is open label and all patients will receive HBI-3000. In each of three dose cohorts, up to 10 patients will receive HBI-3000 by IV infusion (30 minutes). Three different dose levels are planned to be administered serially, lowest to highest, with assessment of safety, tolerability, and efficacy prior to proceeding to the next dose level group. Following Stage A, the iDMC will recommend up to two doses of HBI-3000 to be further explored in Stage B. Stage B is a serial, randomized, double-blind and placebo-controlled cohort of two different doses of HBI-3000, with a dose decision after the first cohort. Stage B will be powered to show a difference between HBI-3000 and placebo in conversion rate at each of the two dose levels.
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Trial website
https://clinicaltrials.gov/study/NCT04680026
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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/NCT04680026