A Clinical Study to Evaluate the Long-term Safety of HRS-1893 in Hypertrophic Cardiomyopathy

NCT ID: NCT07021963

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-04

Study Completion Date

2027-12-31

Brief Summary

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This study mainly evaluates the long-term safety of HRS-1893 in subjects with hypertrophic cardiomyopathy.

Detailed Description

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Conditions

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Hypertrophic Cardiomyopathy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Obstructive Hypertrophic Cardiomyopathy Group

Group Type EXPERIMENTAL

HRS-1893 Tablet

Intervention Type DRUG

HRS-1893 tablet.

Non-obstructive Hypertrophic Cardiomyopathy Group

Group Type EXPERIMENTAL

HRS-1893 Tablet

Intervention Type DRUG

HRS-1893 tablet.

Interventions

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HRS-1893 Tablet

HRS-1893 tablet.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects with hypertrophic cardiomyopathy who have previously completed HRS-1893 related studies.
2. 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.
3. Understand the study procedures and methods, voluntarily participate in this trial, and sign the informed consent form in writing.

Exclusion Criteria

1. Previous history of coronary artery disease (stenosis of one or more coronary arteries \>70%) or myocardial infarction.
2. Have received medication for negative inotropic other than disopyramide, β-blocker, verapamil, diltiazem 4 weeks before screening.
3. History of syncope or sustained ventricular tachycardia within 6 months prior to screening.
4. 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianhong Lv

Role: CONTACT

+86-0518-82342973

Facility Contacts

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Lianming Kang

Role: primary

+86-010-88396870

Other Identifiers

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HRS-1893-205

Identifier Type: -

Identifier Source: org_study_id

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