Treatment protocol of the second international study for hemophagoocytic lymphohistiocytosis (HLH) - HLH-2004
- Conditions
- Hemophagocytic lymphohistiocytosis (HLH)MedDRA version: 14.1Level: PTClassification code 10049646Term: LymphohistiocytosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2006-002391-17-IT
- Lead Sponsor
- AZIENDA DI RILIEVO NAZIONALE E DI ALTA SPECIALIZZAZIONE OSPEDALE CIVICO E BENFRATELLI, G.DI CRISTINA E M.ASCOLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
International criteria: fever, splenomegaly, cytopenia, hypertriglyceridemia, hypofibrinogenemia, defective NK activity
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
None
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To improve the survival of children with HLH;Secondary Objective: Define the genetic diagnosis of patients with HLH;Primary end point(s): Survival at 2 months and 5 years
- Secondary Outcome Measures
Name Time Method