CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Emapalumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02069899
NCT02069899Phase 3Completed
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A Multicenter Study for the Long-term Follow-up of HLH Patients Who Received Treatment With NI-0501, an Anti-interferon Gamma Monoclonal Antibody

Swedish Orphan Biovitrum·interventional·Posted Feb 24, 2014·Updated Jun 28, 2022

In Brief

A Phase 3 clinical trial evaluating Emapalumab for Hemophagocytic Lymphohistiocytosis. Completed, enrolled 58 participants across 16 sites in 5 countries.

Detailed Summary

International, multicenter, long-term, follow-up study that will enrol HLH participants who have received emapalumab in previous clinical trials, in the context of the clinical development program for emapalumab or under compassionate use (CU).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophagocytic Lymphohistiocytosis
CountriesFrance, Italy, Spain, United Kingdom, United States
CollaboratorsSeventh Framework Programme

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2014
Enrollment StartAug 4, 2014
Primary CompletionMay 18, 2021
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 12.4 years ago

Interventions

Emapalumabdrug

Treatment with emapalumab is not planned for all enrolled participants. For participants who will continue receiving emapalumab in the context of this study (NI-0501-05), the dose and timing will be either carried forward from the last administered emapalumab dose as part of the parent study in which the participant was enrolled, or an adjusted dose will be administered, if necessary.