A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
NCT07021963
Phase
Phase 2
Recruitment status
Recruiting
Participants
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Start date
2025-07-04
Number of sites
- Summary
- This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.
- Short title
- A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
- Official title
- A Multicenter, Open-label Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2025-06-15
- Registry last updated
- 2025-09-10
- Primary completion date
- 2027-12-01
- Start date
- 2025-07-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07021963
- ClinicalTrials.gov ID
- NCT07021963
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Incidence and severity of adverse events (AEs).
Timeframe: About 1 year.
Incidence of left ventricular ejection fraction (LVEF) <50%.
Timeframe: About 1 year.
The change in cardiac troponin from baseline.
Timeframe: Week 24 and Week 52.
The change in N-terminal B-type natriuretic peptide (NT-proBNP) from baseline.
Timeframe: Week 24 and Week 52.
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Healthy volunteers
- No
- Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating during the study. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to refrain from donating sperm/eggs from the time they sign the informed consent form until 3 months after the last dose of trial drug, and to comply with relevant contraceptive requirements.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- Previous history of coronary artery disease (stenosis of one or more coronary arteries >70%) or myocardial infarction.
- Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial, such as physical or psychological diseases or conditions that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial.
Sources for eligibility
- Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeBeijing, ChinaRecruiting
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Hypertrophic cardiomyopathy Primary condition