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NCT03312751 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis
A Phase 3 study, sponsored by Swedish Orphan Biovitrum.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT03312751 is a Phase 3 study that has completed, run by Swedish Orphan Biovitrum. The registered enrollment target is 35 participants.
The verdict
NCT03312751, a Phase 3 study, has completed, sponsored by Swedish Orphan Biovitrum.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term outcomes and quality of life assessments. Emapalumab 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 available standard of care. Emapalumab is to be administered until the start of conditioning for hematopoietic stem cell transplantation (HSCT), with an anticipated duration ranging from a minimum of 4 weeks to approximately 12 weeks and not exceeding 6 months. After treatment completion, patients will continue in the study for long-term follow-up until 1 year after either HSCT or last emapalumab infusion (if HSCT is not performed).
Interventions
- DRUG Emapalumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2022-09-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03312751
The ClinicalTrials.gov registry entry for NCT03312751 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 35 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 Emapalumab is the first listed.
NCT03312751 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03312751 about?
NCT03312751 is a clinical study titled "Study to Assess the Efficacy and Safety of Emapalumab in Primary Haemophagocytic Lymphohistiocytosis". The purpose of this study is to expand the knowledge on the efficacy and safety of emapalumab (previously known as NI-0501) as a treatment for primary haemophagocytic lymphohistiocytosis (HLH) patients, including on long-term outcomes and quality of life assessments. Emapalumab can be administered a...
What is the current status of trial NCT03312751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2019-02-06. Estimated completion is 2022-09-14.
What interventions are being tested in trial NCT03312751?
The interventions under investigation include: Emapalumab (DRUG).
Who is sponsoring clinical trial NCT03312751?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
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