CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM)
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ClinicalTrials.gov Identifier: NCT04136171 |
Recruitment Status :
Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : January 23, 2024
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Sponsor:
Ionis Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | October 21, 2019 | ||||||
First Posted Date ICMJE | October 23, 2019 | ||||||
Last Update Posted Date | January 23, 2024 | ||||||
Actual Study Start Date ICMJE | March 13, 2020 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Composite Outcome of Cardiovascular (CV) Mortality and Recurrent CV Clinical Events up to Week 140 [ Time Frame: Baseline up to Week 140 ] | ||||||
Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | CARDIO-TTRansform: A Study to Evaluate the Efficacy and Safety of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) | ||||||
Official Title ICMJE | A Phase 3 Global, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) | ||||||
Brief Summary | To evaluate the efficacy of eplontersen compared to placebo in participants with ATTR-CM receiving available standard of care (SoC). For more information, please visit https://www.cardio-ttransform.com. | ||||||
Detailed Description | This is a multicenter, double-blind study in approximately 1400 participants, who will be randomized to receive subcutaneous (SC) injections of either eplontersen or placebo once every 4 weeks. Participants will also receive daily supplemental doses of the recommended daily allowance of vitamin A. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR CM) | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
1438 | ||||||
Original Estimated Enrollment ICMJE |
750 | ||||||
Estimated Study Completion Date ICMJE | November 2025 | ||||||
Estimated Primary Completion Date | June 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 90 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Poland, Portugal, Puerto Rico, Spain, Sweden, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04136171 | ||||||
Other Study ID Numbers ICMJE | ION-682884-CS2 2019-002835-27 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Ionis Pharmaceuticals, Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Ionis Pharmaceuticals, Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Ionis Pharmaceuticals, Inc. | ||||||
Verification Date | January 2024 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |