Celltrion: CT-G20 in oHCM

Summary

This study focuses on adults (18-70 years old) who have been diagnosed with obstructive hypertrophic cardiomyopathy (oHCM). The purpose of the study is to determine the safety and tolerability of an investigational drug called CT-G20 in people with oHCM. The study will also determine how the drug is distributed within the body and its effects on the body. Obstructive hypertrophic cardiomyopathy is a condition in which heart muscle becomes abnormally thick, and blood flow out of the left ventricle is blocked. Participants will be randomly assigned to receive either CT-G20 or placebo (inactive substance). CT G20 consists of an antiarrhythmic medication (medication used to treat irregular heartbeat) that improves the function of the left ventricle of the heart.


Inclusion Criteria

  • Men or women aged 18 to 70 years, inclusive at Screening
  • Has established diagnosis of HCM defined by standard criteria as a maximal left ventricular wall thickness ≥15 mm at initial diagnosis in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed or ≥13 mm if the subject has a family history of HCM
  • Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-G20 in Subjects with Hypertrophic Obstructive Cardiomyopathy

Details
Disease Type/Condition

Cardiac Surgery

Principal Investigator

Siegel, Robert

Co-Investigators

Florian Rader

Age Group

Adult

Phase

I

IRB Number

STUDY00000822

ClinicalTrials.gov ID

NCT04418297

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Cardiac Surgery

Principal Investigator

Siegel, Robert

Age Group

Adult

Phase

I

IRB Number

CT-G20-12

ClinicalTrials.gov ID

NCT04418297

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?