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NCT03075878 · ClinicalTrials.gov registry record · Phase 1
A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT03075878: Clinical Trial Phase 1 study, sponsored by Alexion Pharmaceuticals.
NCT03075878 is a Phase 1 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03075878, a Phase 1 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.
Primary Outcome
A TEAE was defined as any adverse event that starts on or after the first dose of study drug or occurs prior to the first dose and worsens in severity on or after the first dose of study drug, during the Treatment Period and Follow-up Period. A TEAE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in any of the following outcomes: death, life-threatening adverse drug event, inpatient hospitalization or prolongation of existing hospitalization, persisten
Interventions
- DRUG ALXN1830
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-01-10 |
| Est. Completion | 2019-08-06 |
| Phase | Phase 1 |
Why NCT03075878 stopped before completion
NCT03075878 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which ALXN1830 is the first listed.
NCT03075878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03075878 about?
NCT03075878 is a clinical study titled "A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)". This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.
What is the current status of trial NCT03075878?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2018-01-10. Estimated completion is 2019-08-06.
What interventions are being tested in trial NCT03075878?
The interventions under investigation include: ALXN1830 (DRUG).
Who is sponsoring clinical trial NCT03075878?
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 NCT03075878's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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