Status:
TERMINATED
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
Lead Sponsor:
Celltrion
Conditions:
Cardiomyopathy, Hypertrophic Obstructive
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04418297
Start Date
October 23 2020
End Date
November 22 2022
Last Update
March 2 2023
Active Locations (11)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Tufts Medical Center
Boston, Massachusetts, United States, 02111
3
New York University Langone Medical Center
New York, New York, United States, 10016
4
Independent Public Central Clinical Hospital
Warsaw, Masovian Voivodeship, Poland, 02097