Hypertrophic Cardiomyopathy Clinical Trial

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy

Summary

This is a randomized, double-blind, placebo-controlled, sequential, 5-day treatment, ascending dose study in subjects with obstructive HCM aged 18-70 years. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.

View Eligibility Criteria

Eligibility Criteria

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

Exclusion Criteria:

Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
History of persistent atrial fibrillation prior to Screening or Baseline
History of paroxysmal atrial fibrillation requiring treatment (e.g., anti-coagulation and/or antiarrhythmic therapy) within 3 months prior to Screening
Recently treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation) within 6 months prior to Screening or plans to have either of these treatments during the study
Systolic heart failure with ejection fraction <55% or heart failure symptoms of NYHA Class IV
QTcF >480 msec at Screening or Baseline

Presence of diseases classified as significant by the Investigator at Screening or Baseline, including the following but not limited to:

Diabetes mellitus requiring treatment
Moderate or severe renal insufficiency or renal insufficiency with estimated glomerular filtration rate <70 mL/min/1.73m2
Concomitant use of Disopyramide or Ranolazine within at least 7 days or 5 half-lives (whichever is longer) prior to Screening

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

23

Study ID:

NCT04418297

Recruitment Status:

Terminated

Sponsor:

Celltrion

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There are 11 Locations for this study

See Locations Near You

Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
Tufts Medical Center
Boston Massachusetts, 02111, United States
New York University Langone Medical Center
New York New York, 10016, United States
Seoul National University Bundang Hospital
Seongnam Gyeonggi-do, 13620, Korea, Republic of
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Severance Hospital
Seoul , 03722, Korea, Republic of
Samsung Medical Center
Seoul , 06351, Korea, Republic of
Chung-Ang University Hospital
Seoul , 06973, Korea, Republic of
Independent Public Central Clinical Hospital
Warsaw Mazowieckie, 02097, Poland
Institute of Cardiology in Warsaw
Warsaw Mazowieckie, 04628, Poland

How clear is this clinincal trial information?

Study is for people with:

Hypertrophic Cardiomyopathy

Phase:

Phase 1

Estimated Enrollment:

23

Study ID:

NCT04418297

Recruitment Status:

Terminated

Sponsor:


Celltrion

How clear is this clinincal trial information?

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