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NCT04543591 · ClinicalTrials.gov registry record · Phase 3
Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant
A Phase 3 study of Thrombotic Microangiopathy, sponsored by Alexion Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 148
- Enrollment target
- 20
- Study locations
NCT04543591 is a Phase 3 study of Thrombotic Microangiopathy that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 148 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT04543591, a Phase 3 study of Thrombotic Microangiopathy, is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 148 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be confirmed. In Stage 2, participants will be randomized to receive either blinded ravulizumab plus best supportive care or matching placebo plus best supportive care. The treatment period is 26 weeks (open-label for Stage 1, and randomized, double-blind, and placebo-controlled for Stage 2) followed by a 26-week follow-up period.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Ravulizumab
- OTHER Best supportive care
Study Locations (20)
Other
- Research Site - Parkville
- Research Site - Bruges
- Research Site - Brussels
- Research Site - Chênée
- Research Site - Yvoir
- Research Site - Cerqueira César
- Research Site - Florianópolis
- Research Site - Jaú
- Research Site - Porto Alegre
- Research Site - Porto Alegre
- Research Site - Rio de Janeiro
- Research Site - São José do Rio Preto
- Research Site - São Paulo
- Research Site - Suzhou
Florida
- Research Site - Tampa
Michigan
- Research Site - Grosse Pointe Farms
North Carolina
- Research Site - Durham
Pennsylvania
- Research Site - Pittsburgh
Washington
- Research Site - Seattle
Alberta
- Research Site - Calgary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2026-03-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04543591
The ClinicalTrials.gov registry entry for NCT04543591 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 148 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 1 condition, with Thrombotic Microangiopathy appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT04543591 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Other, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04543591 about?
NCT04543591 is a clinical study titled "Ravulizumab in Thrombotic Microangiopathy After Hematopoietic Stem Cell Transplant". This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ravulizumab in adult and adolescent participants with hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). In Stage 1, an open-label, single-arm period, the dosing regimen will be...
What is the current status of trial NCT04543591?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 148 participants. The study started on 2020-12-10. Estimated completion is 2026-03-20.
What conditions does trial NCT04543591 study?
This clinical trial studies the following conditions: Thrombotic Microangiopathy.
What interventions are being tested in trial NCT04543591?
The interventions under investigation include: Placebo (OTHER), Ravulizumab (BIOLOGICAL), Best supportive care (OTHER).
Who is sponsoring clinical trial NCT04543591?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04543591 being conducted?
This trial has 20 study locations across Florida, Michigan, North Carolina, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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