Status:
COMPLETED
Study to Investigate Safety, Efficacy of an Anti-IFNγ mAb in Children With Primary Haemophagocytic Lymphohistiocytosis
Lead Sponsor:
Swedish Orphan Biovitrum
Collaborating Sponsors:
Seventh Framework Programme
Conditions:
Primary Haemophagocytic Lymphohistiocytosis
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
PHASE3
Brief 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....
Detailed Description
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....
Eligibility Criteria
Inclusion
- Gender: male and female
- Age: up to and including 18 years at diagnosis of Haemophagocytic Lymphohistiocytosis
- Primary HLH patients
- Patient (if ≥ 18 years old), or patient's legal representative(s) must have signed informed consent
Exclusion
- Diagnosis of secondary Haemophagocytic Lymphohistiocytosis consequent to a proven rheumatic or neoplastic disease.
- Body weight \< 3 kg.
- Patients treated with biologics within a specific timeframe
- Active Mycobacteria, Histoplasma Capsulatum, Shigella, Salmonella, Campylobacter and Leishmania infections.
- Presence of malignancy.
- Concomitant disease or malformation severely affecting the cardiovascular, pulmonary, liver or renal function
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01818492
Start Date
July 1 2013
End Date
January 1 2019
Last Update
February 21 2023
Active Locations (20)
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1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045-7106
2
Alfred I. duPont Hospital for Children - Nemours Center for Cancer and Blood Disorders - Division of Pediatric Hematology Oncology
Wilmington, Delaware, United States, 19803
3
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
4
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States, 02115