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Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis

NCT01818492 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-02-21

Study results available
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Summary

The purpose of this study is to assess the safety, tolerability and efficacy of a new drug aimed at controlling disease activity in patients diagnosed with primary haemophagocytic lymphohistiocytosis. The new drug 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 current standard of care. Administration will be on top of a glucocorticosteroid, which is usually part of the current recommended treatment.

Conditions

  • Primary Haemophagocytic Lymphohistiocytosis

Interventions

BIOLOGICAL

NI-0501

Sponsors & Collaborators

  • Seventh Framework Programme

    collaborator OTHER

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Radmila Kanceva, MD · Swedish Orphan Biovitrum

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States
  • Germany
  • Italy
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818492 on ClinicalTrials.gov