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NCT04743804 · ClinicalTrials.gov registry record · Phase 3
Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 16
- Enrollment target
NCT04743804: Clinical Trial Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT04743804 is a Phase 3 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 16 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04743804, a Phase 3 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.
Primary Outcome
TMA response required the following: 1) Normalization of platelet count without transfusion support during the prior 7 days. 2) Normalization of LDH. 3) Improvement in glomerular filtration rate (eGFR) of \>= 30% compared to baseline. Participants must meet each TMA criterion at 2 separate assessments obtained at least 24 hours apart, and any measurement in between.
Interventions
- OTHER Placebo
- BIOLOGICAL Ravulizumab
- OTHER Best Supportive Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2022-12-22 |
| Phase | Phase 3 |
Why NCT04743804 stopped before completion
NCT04743804 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04743804 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04743804 about?
NCT04743804 is a clinical study titled "Ravulizumab in Thrombotic Microangiopathy Associated With a Trigger". This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. ...
What is the current status of trial NCT04743804?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2021-06-29. Estimated completion is 2022-12-22.
What interventions are being tested in trial NCT04743804?
The interventions under investigation include: Placebo (OTHER), Ravulizumab (BIOLOGICAL), Best Supportive Care (OTHER).
Who is sponsoring clinical trial NCT04743804?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04743804's enrollment target sits among peer trials
16 1974th of 2000 higher than 24 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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