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NCT03702829 · ClinicalTrials.gov registry record · Phase 2
24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03702829 is a Phase 2 study that was terminated before completion, run by Brigham and Women's Hospital. The registered enrollment target is 31 participants.
The verdict
NCT03702829, a Phase 2 study, was terminated before completion, sponsored by Brigham and Women's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Transthyretin is a protein produced in the liver that transports thyroid hormone and vitamin A. A single substitution of an amino acid in the structure of TTR can result in a relatively unstable protein, the breakdown products of which (predominantly monomers) aggregate abnormally and produce proteinaceous deposits in nerves and the heart. These deposits are known as amyloid and produce progressive nerve and heart damage. Amyloidosis due to a mutant TTR is usually an autosomal dominant and hence is a familial condition. Wild-type TTR is also capable of producing amyloid deposits which predominantly involves the heart (rather than the nervous system) resulting in a progressive decrease in cardiac function with increasing signs of heart failure. This study aims to determine whether subcutaneous injection of an antisense oligonucleotide drug, known as inotersen, that has been specifically designed to reduce production of the protein transthyretin by the liver, can slow or stop the progression of TTR amyloid cardiomyopathy as compared to historical controls, using advanced echocardiography and cardiac MRI. The study also aims to determine the tolerability and safety of this drug when administered over a 24-month period to patients with TTR amyloid cardiomyopathy.
Interventions
- DRUG Inotersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-02-28 |
| Est. Completion | 2022-01-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03702829
The ClinicalTrials.gov registry entry for NCT03702829 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Inotersen is the first listed.
NCT03702829 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03702829 about?
NCT03702829 is a clinical study titled "24 Month Open Label Study of the Tolerability and Efficacy of Inotersen in TTR Amyloid Cardiomyopathy Patients". Transthyretin is a protein produced in the liver that transports thyroid hormone and vitamin A. A single substitution of an amino acid in the structure of TTR can result in a relatively unstable protein, the breakdown products of which (predominantly monomers) aggregate abnormally and produce protei...
What is the current status of trial NCT03702829?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2019-02-28. Estimated completion is 2022-01-15.
What interventions are being tested in trial NCT03702829?
The interventions under investigation include: Inotersen (DRUG).
Who is sponsoring clinical trial NCT03702829?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
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