ACTIVE_NOT_RECRUITING

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Talk to us

Conditions

Severe HypertriglyceridemiaISIS 678354Olezarsen

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Official Title

An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

Quick Facts

Study Start:2022-12-13
Study Completion:2027-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05681351

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
  2. * Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
  3. * A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

LA Universal Research Center, Inc.
Los Angeles, California, 90057
United States
University of California, San Diego (UCSD)
San Diego, California, 92161
United States
Metabolic Institute of America
Tarzana, California, 91356
United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
United States
Finlay Medical Research
Greenacres City, Florida, 33467
United States
Columbus Clinical Services, LLC
Miami, Florida, 33125
United States
Finlay Medical Research
Miami, Florida, 33126
United States
Innovia Research Center, Inc.
Miramar, Florida, 33027
United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, 33162
United States
R & B Medical Center LLC
Tampa, Florida, 33614
United States
VICIS Clinical Research
Tampa, Florida, 33615
United States
JSV Clinical Research Study, Inc.
Tampa, Florida, 33634
United States
Bayside Clinical Research
Trinity, Florida, 34655
United States
Centricity Research
Columbus, Georgia, 31904
United States
IACT Health
Columbus, Georgia, 31904
United States
Affinity Health
Oak Brook, Illinois, 60523
United States
St. Vincent Medical Group, Inc.
Carmel, Indiana, 46290
United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, 66160
United States
The Research Group of Lexington, LLC
Lexington, Kentucky, 40503
United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, 40213
United States
Grace Research, LLC
Bossier City, Louisiana, 71111
United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201
United States
IRC Clinics
Towson, Maryland, 21204
United States
Massachusetts General Hospital Heart Center
Boston, Massachusetts, 02114
United States
University of Michigan- Endocrinology & Metabolism
Ann Arbor, Michigan, 48109
United States
Aa Mrc, Llc
Flint, Michigan, 48504
United States
Washington School of Medicine
St Louis, Missouri, 63110
United States
Bryan Medical Center
Lincoln, Nebraska, 68506
United States
Palm Research Center, Inc.
Las Vegas, Nevada, 89128
United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, 07087
United States
Modern Medical
Brooklyn, New York, 33709
United States
NYU Langone Health
Mineola, New York, 11501
United States
Langone Medical Center
New York, New York, 10016
United States
Vagelos College of Physicians and Surgeons of Columbia University
New York, New York, 10032
United States
Orchard Park Family Practice
Orchard Park, New York, 14127
United States
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
United States
Kenneth Hilty
Greensboro, North Carolina, 27401
United States
Clinical Trials of America, LLC
Lenoir, North Carolina, 28645
United States
Lexington
Winston-Salem, North Carolina, 27103
United States
The Ohio State University
Columbus, Ohio, 43203
United States
Central Oklahoma Early Detection Center
Edmond, Oklahoma, 73034
United States
Oklahoma Heart Institute
Tulsa, Oklahoma, 74104
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Walker Family Care
Little River, South Carolina, 29566
United States
Monument Health Clinical Research
Rapid City, South Dakota, 57701
United States
Health Concepts
Rapid City, South Dakota, 57702
United States
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, 37404
United States
The Jackson Clinic
Jackson, Tennessee, 38301
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Juno Research
Houston, Texas, 77040
United States
Pioneer Research Solutions
Houston, Texas, 77099
United States
Sante Clinical Research LLC
Kerrville, Texas, 78028
United States
FMC Science
Lampasas, Texas, 76550
United States
DCT- McAllen Primary Care, LLC
McAllen, Texas, 78503
United States
Texas Institute of Cardiology
McKinney, Texas, 75071
United States
SMS Clinical Research, LLC
Mesquite, Texas, 75149
United States
Southern Endocrinology Associates
Mesquite, Texas, 75149
United States
Permian Research Foundation
Odessa, Texas, 79761
United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
United States
Tranquil Clinical and Research Consulting Services
Webster, Texas, 77598
United States
Manassas Clinical Research
Manassas, Virginia, 20110
United States
York Clinical Research
Norfolk, Virginia, 23510
United States
WVU Heart and Vascular Institute
Morgantown, West Virginia, 26506
United States

Collaborators and Investigators

Sponsor: Ionis Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-13
Study Completion Date2027-03

Study Record Updates

Study Start Date2022-12-13
Study Completion Date2027-03

Terms related to this study

Keywords Provided by Researchers

  • ISIS 678354
  • Olezarsen

Additional Relevant MeSH Terms

  • Severe Hypertriglyceridemia