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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418297
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

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 safety, tolerability, pharmacokinetics and pharmacodynamics of CT-G20.

Condition or disease Intervention/treatment Phase
Cardiomyopathy, Hypertrophic Obstructive Drug: CT-G20 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic Cardiomyopathy
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: CT-G20 Drug: CT-G20
oral tablet

Placebo Comparator: Placebo Drug: Placebo
oral tablet




Primary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events and their relationship to the investigational product [ Time Frame: 12 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Has LVOT gradient ≥30 mmHg at rest or LVOT gradient ≥50 mmHg with Valsalva maneuver, due to SAM

Exclusion Criteria:

  1. Known infiltrative, genetic or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis or Noonan syndrome with LV hypertrophy
  2. Systolic heart failure with ejection fraction <55% or heart failure symptoms of NYHA Class IV

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418297


Contacts
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Contact: Boram Lee +82-2-3403-9659 boram.lee@celltrion.com

Locations
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United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
United States, New York
New York University Langone Medical Center Not yet recruiting
New York, New York, United States, 10016
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Poland
Independent Public Central Clinical Hospital Not yet recruiting
Warsaw, Mazowieckie, Poland, 02097
Institute of Cardiology in Warsaw Not yet recruiting
Warsaw, Mazowieckie, Poland, 04628
Sponsors and Collaborators
Celltrion
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04418297    
Other Study ID Numbers: CT-G20 1.2
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases