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A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HBI-3000
Placebo
Sponsored by
HUYABIO International, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring cardioversion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Sites / Locations

  • Grandview Medical Group Research
  • HonorHealth Research Institute and InnovationRecruiting
  • NCH Research InstituteRecruiting
  • Research Physicians Network Alliance/Florida Cardiology
  • Prairie Education & Research
  • St. Vincent Heart CenterRecruiting
  • Lutheran Hospital
  • UofL Health - UofL Physicians, Cardiology AssociatesRecruiting
  • North Mississippi Medical CenterRecruiting
  • AMG Heart and Vascular CenterRecruiting
  • Ascension St. John Clinical Research InstituteRecruiting
  • CHRISTUS Trinity Mother Frances Hospital - TylerRecruiting
  • Gold Coast University HospitalRecruiting
  • University Clinical Center of the Republic of SrpskaRecruiting
  • University Clinical Center TuzlaRecruiting
  • Montreal Heart InstituteRecruiting
  • Centre hospitalier de L'Universite de Montral (CHUM)Recruiting
  • Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le GardeurRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Chonnam National University HospitalRecruiting
  • Auckland City Hospital
  • Waikato Hospital
  • Wellington Regional HospitalRecruiting
  • University Clinical Center of SerbiaRecruiting
  • University Hospital Medical Center Bezanijska kosaRecruiting
  • Clinical Hospital Center ZvezdaraRecruiting
  • Health Center UziceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Drug: HBI-3000, Stage A Dose Level 1

Drug: HBI-3000, Stage A Dose Level 2

Drug: HBI-3000, Stage A Dose Level 3

Drug: HBI-3000, Stage B Dose Level 1

Drug: HBI-3000, Stage B Dose Level 2

Arm Description

Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results

Outcomes

Primary Outcome Measures

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)
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)
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)
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
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)
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
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
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
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
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

Secondary Outcome Measures

Evaluate the time to conversion to SR from start of infusion
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
Evaluate the proportion of patients with sustained AF or late conversion to SR
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

Full Information

First Posted
December 17, 2020
Last Updated
September 28, 2023
Sponsor
HUYABIO International, LLC.
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1. Study Identification

Unique Protocol Identification Number
NCT04680026
Brief Title
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HUYABIO International, LLC.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This is a two-stage study in patients with AF of recent onset: 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). For each dosing cohort, sentinel dosing is planned. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment. In Stage A, 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. The actual dose levels may be modified, and additional dose levels may be considered based on the observed results at each cohort. Stage B is the randomized, double-blind and placebo-controlled part of the study. Study drug for Stage B patients is either HBI-3000 or placebo. Two cohorts will be enrolled sequentially, lowest dose level first, with safety, efficacy, and available PK results evaluated by the Sponsor and iDMC prior to enrolling patients in the next/higher dose cohort. The dose level for the second cohort may be adjusted following interim review of results in the first cohort. Patients will be randomized to receive a single IV infusion of HBI 3000 or placebo over 30 minutes. In each of the dose cohorts, sequentially enrolled patients will be randomized at 2:1 ratio so that 40 patients will receive HBI 3000 infusion and 20 patients will receive placebo infusion. Each patient may enroll only once in the study, will be enrolled into only one dose cohort and receive only a single dose treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
cardioversion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Allocation: Stage A: non-randomized; Stage B: randomized, double-blind and placebo-controlled Intervention Model: Two-stage study Masking: None; Stage A (open label); Stage B: randomized, double-blind and placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Drug: HBI-3000, Stage A Dose Level 1
Arm Type
Experimental
Arm Description
Stage A Open Label HBI-3000 Dose Level 1: 200 mg
Arm Title
Drug: HBI-3000, Stage A Dose Level 2
Arm Type
Experimental
Arm Description
Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned
Arm Title
Drug: HBI-3000, Stage A Dose Level 3
Arm Type
Experimental
Arm Description
Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned
Arm Title
Drug: HBI-3000, Stage B Dose Level 1
Arm Type
Experimental
Arm Description
Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results
Arm Title
Drug: HBI-3000, Stage B Dose Level 2
Arm Type
Experimental
Arm Description
Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results
Intervention Type
Drug
Intervention Name(s)
HBI-3000
Other Intervention Name(s)
sulcardine sulfate
Intervention Description
Small molecule, multi-ion channel blocker
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
30 days
Title
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)
Description
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
Time Frame
90 minutes
Title
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)
Description
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
Time Frame
90 minutes
Title
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
Description
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
Time Frame
24 hours
Title
The efficacy of intravenously (IV) administered HBI-3000 as measured by the proportion of patients with AF of recent onset who convert to SR
Description
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
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Evaluate the time to conversion to SR from start of infusion
Description
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
Time Frame
24 hours
Title
Evaluate the proportion of patients with sustained AF or late conversion to SR
Description
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
Time Frame
12 hours, 24 hours and 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerry Riebman, MD, FACS, FACC
Phone
858-798-8800
Email
jriebman@huyabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suzanne Romano, PhD
Phone
858-798-8800
Email
sromano@huyabio.com
Facility Information:
Facility Name
Grandview Medical Group Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Individual Site Status
Withdrawn
Facility Name
HonorHealth Research Institute and Innovation
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue DerbyShire
Phone
480-323-1046
Email
SDerbyShire@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Rahul Doshi, MD
Facility Name
NCH Research Institute
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Byrd
Phone
239-624-8113
Email
kathy.byrd@nchmd.org
First Name & Middle Initial & Last Name & Degree
Dinesh Sharma, MD
Facility Name
Research Physicians Network Alliance/Florida Cardiology
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Withdrawn
Facility Name
Prairie Education & Research
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Individual Site Status
Terminated
Facility Name
St. Vincent Heart Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Verel
Phone
317-388-8042
Email
kelly.verel@ascension.org
First Name & Middle Initial & Last Name & Degree
Parin Patel, MD
Facility Name
Lutheran Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Individual Site Status
Withdrawn
Facility Name
UofL Health - UofL Physicians, Cardiology Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Copeland
Phone
502-540-3409
Email
stephanie.copeland@uoflhealth.org
First Name & Middle Initial & Last Name & Degree
Naresh Solankhi, MD
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Ray
Phone
662-377-5447
Email
yray@nmhs.net
First Name & Middle Initial & Last Name & Degree
James E Stone, Jr, MD
Facility Name
AMG Heart and Vascular Center
City
Bartlesville
State/Province
Oklahoma
ZIP/Postal Code
74006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anderson Mehrle, MD
First Name & Middle Initial & Last Name & Degree
Anderson Mehrle, MD
Facility Name
Ascension St. John Clinical Research Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicholas Hanna, MD
Phone
918-744-3426
Email
nicholas.hanna@ascension.org
First Name & Middle Initial & Last Name & Degree
Nicholas Hanna, MD
Facility Name
CHRISTUS Trinity Mother Frances Hospital - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Wylie
Phone
903-606-3737
Email
jamiecrystal.wylie@christushealth.org
First Name & Middle Initial & Last Name & Degree
Stanislav Weiner, MD
Facility Name
Gold Coast University Hospital
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satyajit R Jayasinghe, MD
First Name & Middle Initial & Last Name & Degree
Satyajit R Jayasinghe, MD
Facility Name
University Clinical Center of the Republic of Srpska
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamara Kovacevic-Preradovic, MD, PhD
Phone
+387 66 941391
Email
tamara.kovacevic@medicolaser.info
First Name & Middle Initial & Last Name & Degree
Tamara Kovacevic-Preradovic, MD, PhD
Facility Name
University Clinical Center Tuzla
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elnur Smajic, MD
Phone
+387 61 185437
Email
elnurs@gmail.com
First Name & Middle Initial & Last Name & Degree
Elnur Smajic, MD
Facility Name
Montreal Heart Institute
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Roy, MD
Facility Name
Centre hospitalier de L'Universite de Montral (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benoit Coutu, MD
Facility Name
Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilbert Gosselin, MD
First Name & Middle Initial & Last Name & Degree
Gilbert Gosselin, MD
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Il-Young Oh, MD
First Name & Middle Initial & Last Name & Degree
Il-Young Oh, MD
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Hong Lee, MD
First Name & Middle Initial & Last Name & Degree
Ki Hong Lee, MD
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Withdrawn
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand
Individual Site Status
Completed
Facility Name
Wellington Regional Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Nurse
Phone
04 918 5117
Facility Name
University Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milika Asanin, MD
First Name & Middle Initial & Last Name & Degree
Mikka Asanin, MD
Facility Name
University Hospital Medical Center Bezanijska kosa
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marija Zdravkovic, MD
Phone
+381 64 8114258
Email
sekcija.kardioloska@gmail.com
First Name & Middle Initial & Last Name & Degree
Marija Zdravkovic, MD
Facility Name
Clinical Hospital Center Zvezdara
City
Belgrade
ZIP/Postal Code
11120
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bojan Jasovic, MD
First Name & Middle Initial & Last Name & Degree
Bojan Jasovic, MD
Facility Name
Health Center Uzice
City
Užice
ZIP/Postal Code
31000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadezda Trifunovic, MD
First Name & Middle Initial & Last Name & Degree
Nadezda Trifunovic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)

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