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

Completed · Phase 2/Phase 3

Conditions studied: Primary Haemophagocytic Lymphohistiocytosis

In brief

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.

Key facts

Study ID

NCT01818492

Run by

Swedish Orphan Biovitrum

People needed

45

Starts

2013-07-01

Expected to finish

2019-01-01

Last updated by the study team

2023-02-21

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Colorado — Aurora, Colorado, United States
• Alfred I. duPont Hospital for Children - Nemours Center for Cancer and Blood Disorders - Division of Pediatric Hematology Oncology — Wilmington, Delaware, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Dana-Farber Cancer Institute (DFCI) — Boston, Massachusetts, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital - Division of Immunobiology - Department of Pediatrics — Cincinnati, Ohio, United States
• Texas Children's Cancer Center — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• University Children's Hospital — Münster, Germany
• Azienda Ospedaliero Universitaria Meyer — Florence, Italy
• Istituto Giannina Gaslini — Genoa, Italy
• Azienda Ospedaliera San Gerardo — Monza, Italy
• Azienda Ospedaliera Padova - Clinica di Oncoematologia Pediatrica — Padua, Italy
• Ospedale Pediatrico Bambino Gesu' — Roma, Italy
• Ospedale Donna Bambino - U.O.C. Oncoematologia Pediatrica — Verona, Italy
• Hospital Sant Joan de Déu — Barcelona, Spain
• Hospital Universitario Vall d'Hebron — Barcelona, Spain
• Hospital Universitario Niño Jesús — Madrid, Spain
• Karolinska University Hospital — Stockholm, Sweden
• Great Ormond Street Hospital - Department of Haematology — London, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.