Status:
ACTIVE_NOT_RECRUITING
A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Lead Sponsor:
HUYABIO International, LLC.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 fibrillatio...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04680026
Start Date
June 1 2021
End Date
December 31 2025
Last Update
December 2 2025
Active Locations (14)
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1
NCH Research Institute
Naples, Florida, United States, 34102
2
Prairie Education & Research
Springfield, Illinois, United States, 62701
3
North Mississippi Medical Center
Tupelo, Mississippi, United States, 38801
4
CHRISTUS Trinity Mother Frances Hospital - Tyler
Tyler, Texas, United States, 75701