Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03985423
Status:
TERMINATED
Last Update Posted:
2023-10-06
First Post:
2019-05-23
Brief Title:
A Study to Evaluate the Efficacy Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH
Sponsor:
Swedish Orphan Biovitrum
Organization:
Swedish Orphan Biovitrum
Study Overview
Official Title:
A Phase 23 Open-label Single Arm Multicenter Study to Evaluate the Efficacy Safety and Pharmacokinetics of Emapalumab in Adult Patients With Hemophagocytic Lymphohistiocytosis
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hemophagocytic lymphohistiocytosis HLH is a rare life-threatening condition characterized by uncontrolled hyperinflammation which may develop on the background of several clinical conditions eg 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
Detailed Description:
Study NI-0501-10 is an open-label single arm multicenter Phase 23 interventional study
The study enrolls adult patients with hemophagocytic lymphohistiocytosis HLH specifically newly diagnosed patients with malignancy-associated HLH M-HLH and newly diagnosed or previously treated patients with non-malignancy-associated HLH
The study enrolls adult patients with hemophagocytic lymphohistiocytosis HLH specifically newly diagnosed patients with malignancy-associated HLH M-HLH and newly diagnosed or previously treated patients with non-malignancy-associated HLH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None