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NCT01818492 · ClinicalTrials.gov registry record · Phase 2
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
A Phase 2 study, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT01818492 is a Phase 2 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 45 participants.
The verdict
NCT01818492, a Phase 2 study, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with the current standard of care, or can be given to patients who have either failed or were unable to tolerate the current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.
Interventions
- BIOLOGICAL NI-0501
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-07 |
| Est. Completion | 2019-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01818492
The ClinicalTrials.gov registry entry for NCT01818492 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Swedish Orphan Biovitrum, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NI-0501 is the first listed.
NCT01818492 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01818492 about?
NCT01818492 is a clinical study titled "Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis". The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug can be administered as the first-line therapy, to patients not previously treated with...
What is the current status of trial NCT01818492?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2013-07. Estimated completion is 2019-01.
What interventions are being tested in trial NCT01818492?
The interventions under investigation include: NI-0501 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01818492?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
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