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NCT03985423 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
A Phase 2 study, sponsored by Swedish Orphan Biovitrum.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03985423 is a Phase 2 study that was terminated before completion, run by Swedish Orphan Biovitrum. The registered enrollment target is 7 participants.
The verdict
NCT03985423, a Phase 2 study, was terminated before completion, sponsored by Swedish Orphan Biovitrum.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). Emapalumab (previously referred to as NI-0501) is a monoclonal antibody neutralizing interferon-gamma (IFN-gamma), a key cytokine driving the inflammation and tissue damage seen in HLH. The purpose of this study is to assess the efficacy, safety and pharmacokinetics of emapalumab in adult patients with secondary HLH.
Interventions
- DRUG Emapalumab-Lzsg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-06-02 |
| Est. Completion | 2021-06-29 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03985423
The ClinicalTrials.gov registry entry for NCT03985423 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 7 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-Lzsg is the first listed.
NCT03985423 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03985423 about?
NCT03985423 is a clinical study titled "A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH". Hemophagocytic lymphohistiocytosis (HLH) is a rare, life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions (e.g. autoimmune disease, infection, malignancy). Emapalumab (previously referred to as NI-0501) is a mono...
What is the current status of trial NCT03985423?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2020-06-02. Estimated completion is 2021-06-29.
What interventions are being tested in trial NCT03985423?
The interventions under investigation include: Emapalumab-Lzsg (DRUG).
Who is sponsoring clinical trial NCT03985423?
This trial is sponsored by Swedish Orphan Biovitrum, which has 23 total clinical trials registered on ClinicalTrials.gov.
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