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NCT04304144 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT04304144 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 25 participants.
The verdict
NCT04304144, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous system and digestive tract. The primary purpose of this study is to determine the recommended dose of CAEL-101 to facilitate progression of further clinical trials and evaluate safety and tolerability of CAEL-101 in combination with the standard of care (SoC) cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy and daratumumab .
Interventions
- DRUG Daratumumab
- DRUG CAEL-101
- DRUG SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04304144
The ClinicalTrials.gov registry entry for NCT04304144 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Daratumumab is the first listed.
NCT04304144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04304144 about?
NCT04304144 is a clinical study titled "A Study to Evaluate the Safety and Tolerability of CAEL-101 in Patients With AL Amyloidosis". AL amyloidosis begins in the bone marrow where abnormal proteins misfold and create free light chains that cannot be broken down. These free light chains bind together to form amyloid fibrils that build up in the extracellular space of organs, affecting the kidneys, heart, liver, spleen, nervous sys...
What is the current status of trial NCT04304144?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2020-03-18. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT04304144?
The interventions under investigation include: Daratumumab (DRUG), CAEL-101 (DRUG), SoC: cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) (DRUG).
Who is sponsoring clinical trial NCT04304144?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
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