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A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
NCT04680026 · View on ClinicalTrials.gov ↗
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
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HUYABIO International, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04680026 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Other, Quebec, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04680026?
The interventions under investigation include: Placebo (DRUG), HBI-3000 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04680026?
This trial is sponsored by HUYABIO International, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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