Clinical trial
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With…
NCT01818492 · Swedish Orphan Biovitrum, Industry · Completed
Key facts
| NCT number | NCT01818492 |
|---|---|
| Title | Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis |
| Official title | A Phase 2/3 Open-label Single Arm Multicentre Study to Assess Safety Tolerability Pharmacokinetics and Efficacy of i.v. Administrations of NI-0501 an Anti-IFNγ mAb in Paediatric Patients With Primary Haemophagocytic Lymphohistiocytosis |
| Lead sponsor | Swedish Orphan Biovitrum, Industry |
| Collaborators | Seventh Framework Programme |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Primary Haemophagocytic Lymphohistiocytosis |
| Intervention type | Biological |
| Interventions | NI-0501 |
| Enrollment | 45 |
| Start date | Jul 1, 2013 |
| Primary completion | Jan 1, 2019 |
| Completion | Jan 1, 2019 |
| First posted | Mar 26, 2013 |
| Last update posted | Feb 21, 2023 |
| Countries | Germany, Italy, Spain, Sweden, United Kingdom, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: