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NCT02245412 · ClinicalTrials.gov registry record · Phase 2
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT02245412: Clinical Trial Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT02245412 is a Phase 2 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02245412, a Phase 2 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.
Primary Outcome
The number of participants with overall acute GVHD response was determined at Day 28. Acute Overall GVHD is defined as improvement from diagnosis in any organ by at least 1 stage, without progression in any other organ, and with no additional therapy being administered. Acute GVHD staging included skin, liver, and GI assessments, which were to be performed using the Modified Keystone Grading Schema. Deaths were considered nonresponders; otherwise last postbaseline values were carried forward for
Interventions
- BIOLOGICAL ALXN1007 10 mg/kg once weekly
- BIOLOGICAL ALXN1007 20 mg/kg once weekly
- BIOLOGICAL ALXN1007 20 mg/kg twice weekly
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2014-11-14 |
| Est. Completion | 2017-02-27 |
| Phase | Phase 2 |
Why NCT02245412 stopped before completion
NCT02245412 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which ALXN1007 10 mg/kg once weekly is the first listed.
NCT02245412 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02245412 about?
NCT02245412 is a clinical study titled "A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease". The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.
What is the current status of trial NCT02245412?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2014-11-14. Estimated completion is 2017-02-27.
What interventions are being tested in trial NCT02245412?
The interventions under investigation include: ALXN1007 10 mg/kg once weekly (BIOLOGICAL), ALXN1007 20 mg/kg once weekly (BIOLOGICAL), ALXN1007 20 mg/kg twice weekly (BIOLOGICAL).
Who is sponsoring clinical trial NCT02245412?
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 NCT02245412's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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