Children and Adult Hemophagocytic Syndrome (HLHa) (NCT02113917) | Clinical Trial Compass
CompletedNot Applicable
Children and Adult Hemophagocytic Syndrome (HLHa)
France204 participantsStarted 2010-01
Plain-language summary
Different study of HLHa patients :
* Diagnosis criteria, because criteria are based on pediatric genetic studies.
* Physiopathological studies: genetic studies have demonstrated the role of CD8+ cells, in particular because they have a genetic defect affecting their cytotoxic functions in HLH pediatric. the aim is to establish if the same defect is found in both some or in all of HLHa patients. If this is the case, to then establish whether hypomorphic genetic mutations are responsible.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Major criteria:
* hemophagocytosis found in a specimen histology.
* Fever
* Splenomegaly
Minor criteria:
* adenopathy
* cytopenia\> 2 cell lines Hemoglobin \<9 g / dl (less than 4 weeks and\> 12 g / dl) Platelets \<100 000 x 10 / l Neutrophils \<1 10 / l
* hypertriglyceridaemia and / or hypofibrinogenaemia Elevated triglycerides\> 3 mmol / l Fibrinogen \<1.5 g / l
* Ferritin\> 500 microg / L
These criteria will be those used for the diagnosis of HLH in adults:
One major criterion and two minor (including hyper ferritin or hypertriglyceridemia) 3 minor criteria (including hyper ferritin or hypertriglyceridemia)
Exclusion Criteria:
* Pregnant women
* A person under guardianship
* Patients under the age of 2 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
biologicals criteria
Timeframe: T0 (before traitment
2
name of treatment
Timeframe: T2 (T2 is the first day of treatment)
3
Clinicals criteria
Timeframe: T0
4
biologicals criteria
Timeframe: T1 (T1 is the first day of HLH syndrome)
5
biologicals criteria
Timeframe: T2 (T2 is the first day of treatment)
6
biologicals criteria
Timeframe: T4 (6 /12 months after the resolution of HLH)
7
Clinicals criteria
Timeframe: T1(T1 is the first day of HLH syndrome)