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HBI-3000 for Atrial Fibrillation

Phase 2

Waitlist Available

Research Sponsored by HUYA Bioscience International

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 hours, 24 hours and 7 days

Awards & highlights

Study Summary

This trial is a two-stage study of HBI-3000, a drug used to convert patients with recent-onset atrial fibrillation. In stage A, patients will receive the drug in escalating doses to assess safety and efficacy. In stage B, the most effective dose will be determined in a placebo-controlled setting.

Who is the study for?

This trial is for adults aged 18-80 with recent-onset atrial fibrillation lasting more than 2 hours but less than 72. Participants must be eligible for cardioversion and on or suitable for anticoagulant therapy. Exclusions include severe heart issues, certain past medical events like stroke, use of specific drugs, ECG abnormalities such as long QT syndrome, and those in other drug/device trials.Check my eligibility

What is being tested?

The study tests HBI-3000's ability to convert recent-onset atrial fibrillation to a normal rhythm via IV infusion. Stage A involves escalating doses in cohorts; all receive the drug. Stage B compares two selected doses against placebo in a randomized, double-blind setup to determine efficacy.See study design

What are the potential side effects?

While specific side effects are not listed here, potential risks may include reactions related to heart rhythm changes (like palpitations), issues from IV infusion (such as infection at the site), and any general medication-related side effects which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 hours, 24 hours and 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 hours, 24 hours and 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 hours, 24 hours and 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by ECG interval changes above a specific level

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by change in blood pressure (BP)

Evaluate the safety of intravenously (IV) administered HBI-3000 in patients with Atrial Fibrillation (AF) of recent onset, as measured by changes in heart rate (HR)

+2 more

Secondary outcome measures

Evaluate the proportion of patients with sustained AF or late conversion to SR

Evaluate the time to conversion to SR from start of infusion

Trial Design

5Treatment groups

Experimental Treatment

Group I: Drug: HBI-3000, Stage B Dose Level 2Experimental Treatment2 Interventions

Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results

Group II: Drug: HBI-3000, Stage B Dose Level 1Experimental Treatment2 Interventions

Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results

Group III: Drug: HBI-3000, Stage A Dose Level 3Experimental Treatment1 Intervention

Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned

Group IV: Drug: HBI-3000, Stage A Dose Level 2Experimental Treatment1 Intervention

Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned

Group V: Drug: HBI-3000, Stage A Dose Level 1Experimental Treatment1 Intervention

Stage A Open Label HBI-3000 Dose Level 1: 200 mg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HBI-3000

2021

Completed Phase 1

~90

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

HUYA Bioscience InternationalLead Sponsor

8 Previous Clinical Trials

738 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

47 Patients Enrolled for Atrial Fibrillation

HUYABIO International, LLC.Lead Sponsor

11 Previous Clinical Trials

829 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

47 Patients Enrolled for Atrial Fibrillation

Media Library

IV HBI-3000 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04680026 — Phase 2

Atrial Fibrillation Research Study Groups: Drug: HBI-3000, Stage B Dose Level 2, Drug: HBI-3000, Stage A Dose Level 1, Drug: HBI-3000, Stage A Dose Level 2, Drug: HBI-3000, Stage A Dose Level 3, Drug: HBI-3000, Stage B Dose Level 1

Atrial Fibrillation Clinical Trial 2023: IV HBI-3000 Highlights & Side Effects. Trial Name: NCT04680026 — Phase 2

IV HBI-3000 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04680026 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What populations are eligible for participation in this medical experiment?

"To join this research study, individuals must be between 18 and 80 years of age, as well as suffering from atrial fibrillation. The recruitment process is expected to require roughly 150 volunteers."

Answered by AI

How many participants have enrolled in this clinical trial?

"To fully complete this medical trial, 150 qualified participants must be enrolled. For convenience and accessibility, enrolment is available at HonorHealth Research Institute and Innovation in Scottsdale, Arizona or Lutheran Hospital in Fort Wayne, Indiana."

Answered by AI

To what degree does HBI-3000 pose a threat to human health?

"Based on the available information, HBI-3000 was deemed to possess a safety rating of 2. This is because while Phase 2 trials have provided evidence concerning it's security, there has been no data elucidating its efficacy thus far."

Answered by AI

How many health facilities are engaged in this research endeavor?

"This trial is available at 14 different sites, which include HonourHealth Research Institute and Innovation in Scottsdale; Lutheran Hospital in Fort Wayne; North Mississippi Medical Center in Tupelo; concurrently 12 additional locations."

Answered by AI

Is enrollment in this clinical trial still ongoing?

"Affirmative. According to information posted on clinicaltrials.gov, this medical trial is still accepting participants and began recruiting on June 1st 2021. The most recent update was made October 27th 2022 and the study requires 150 people from 12 different sites."

Answered by AI

Is this clinical study admitting geriatric participants?

"The age range for participants in this medical trial is 18 to 80. There are 11 sub-trials available to individuals below the legal age of consent, while 472 trials can accommodate those senior citizens aged 65 and up."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04680026.

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