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

Launched by HUYABIO INTERNATIONAL, LLC. · Dec 17, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HBI-3000, which is given through an IV (a small tube inserted into a vein) to see if it can help convert recent-onset atrial fibrillation (AF) back to a normal heartbeat. Atrial fibrillation is a condition where the heart beats irregularly and can lead to serious complications if not treated. The trial is in Phase 2, which means it's testing the treatment's safety and effectiveness in people who have had AF for more than 2 hours but less than 72 hours. To be eligible, participants need to be between 18 and 80 years old and receiving the right blood thinners to help prevent blood clots during and after the treatment.

Participants in this trial can expect to receive a 30-minute infusion of HBI-3000. The study has two stages: the first stage will give different doses of the medication to assess how safe and effective it is, and if it works, the second stage will compare the best doses against a placebo (a treatment that looks the same but has no active drug). It's important to note that certain health conditions and medications might make someone ineligible for the trial, such as having AF for less than 2 hours or more than 72 hours, or serious heart issues. Overall, this trial aims to find a potential new treatment option for people experiencing recent AF.

Gender

ALL

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