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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: Active Phase 2 study of Atrial Fibrillation, sponsored by HUYABIO International.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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)
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04680026 still lists
NCT04680026 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 2,996-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (95% lower).
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 lists 14 locations in 7 states (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.
Learn More About Clinical Trials
Similar trials for Atrial Fibrillation
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Where NCT04680026's enrollment target sits among peer trials
150 119th of 202 higher than 81 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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