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NCT04680026 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Atrial Fibrillation, sponsored by HUYABIO International.

Active
Registry status
Phase 2
Development phase
150
Enrollment target
14
Study locations

NCT04680026 is a Phase 2 study of Atrial Fibrillation that is active but no longer recruiting, run by HUYABIO International. The registered enrollment target is 150 participants, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The trial reports 14 study locations across 7 states.

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The verdict

NCT04680026, a Phase 2 study of Atrial Fibrillation, is active but no longer recruiting, sponsored by HUYABIO International.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
150 participants
Enrollment target
14
Study locations

Study 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.

Conditions Studied

Atrial Fibrillation

Interventions

  • DRUG Placebo
  • DRUG HBI-3000

Study Locations (14)

Other

  • University Clinical Center of the Republic of Srpska - Banja Luka
  • Waikato Hospital - Hamilton
  • Wellington Regional Hospital - Wellington
  • University Clinical Center of Serbia - Belgrade
  • Dedinje Institute for Cardiovascular Diseases - Belgrade
  • University Hospital Medical Center Bezanijska kosa - Belgrade

Quebec

  • Montreal Heart Institute - Montreal
  • Centre hospitalier de L'Universite de Montral (CHUM) - Montreal
  • Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le Gardeur - Terrebonne

Florida

  • NCH Research Institute - Naples

Illinois

  • Prairie Education & Research - Springfield

Mississippi

  • North Mississippi Medical Center - Tupelo

Texas

  • CHRISTUS Trinity Mother Frances Hospital - Tyler - Tyler

Bulevar Doktora

  • Niš University Clinical Center - Niš

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2021-06-01
Est. Completion 2025-12-31
Phase Phase 2

Sponsor

HUYABIO International

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04680026

The ClinicalTrials.gov registry entry for NCT04680026 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower). The listed sponsor is HUYABIO International, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04680026 reports 14 study locations spanning 7 distinct geographic areas - top geographies include Other, Quebec, Florida.

Frequently Asked Questions

What is clinical trial NCT04680026 about?

NCT04680026 is a clinical study titled "A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)". 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...

What is the current status of trial NCT04680026?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2021-06-01. Estimated completion is 2025-12-31.

What conditions does trial NCT04680026 study?

This clinical trial studies the following conditions: Atrial Fibrillation.

What interventions are being tested in trial NCT04680026?

The interventions under investigation include: Placebo (DRUG), HBI-3000 (DRUG).

Who is sponsoring clinical trial NCT04680026?

This trial is sponsored by HUYABIO International, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04680026 being conducted?

This trial has 14 study locations across Florida, Illinois, Mississippi, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.