A Phase II Clinical Study of HRS-1893 in Non-obstructive Hypertrophic Cardiomyopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-1893, HRS-1893 placebo.
- Who it may be relevant to
- Registry conditions: Non-obstructive Hypertrophic Cardiomyopathy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Double-blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1893 in Non-Obstructive Hypertrophic Cardiomyopathy
Overview
This study mainly evaluated the safety and tolerability of HRS-1893 in subjects with non-obstructive hypertrophic cardiomyopathy, and the efficacy and plasma concentrations of different dosing regimens in subjects with non-obstructive hypertrophic cardiomyopathy.
Interventions
- Drug HRS-1893
HRS-1893 tablet. - Drug HRS-1893 placebo
HRS-1893 tablet placebo.
Primary outcome measures
- Adverse events (AEs) [Time frame: Up to 14 weeks.]
- The incidence of left ventricular ejection fraction (LVEF) < 50% [Time frame: Up to 14 weeks.]
Secondary outcome measures (2)
- Peak oxygen uptake (pVO2) value [Time frame: About 12 weeks.]
- The cardiac troponin value [Time frame: About 12 weeks.]
Eligibility criteria
Inclusion criteria
- Age 18\~85 years old (including boundary value), male or female.
- Body mass index < 35 kg/m2.
- Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.
- Female subjects of childbearing potential must have a serum pregnancy test prior to the first dose with a negative result 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 of signing the informed consent form until 3 months after the last dose of the trial drug, and comply with the relevant contraceptive requirements.
Exclusion criteria
- Known or suspected infiltration, hereditary, or storage disorder that can cause myocardial hypertrophy.
- Paroxysmal atrial flutter or atrial fibrillation with clinical symptoms at screening.
- History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
- Those who have participated in the clinical trial of any drug or medical device within 3 months before screening.
- Other conditions that the investigator considers the subject to be unsuitable for participating in this trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fuwai Hospital — Beijing
Identifiers
NCT: NCT06816251 · HRS-1893-202