CompletedNot Applicable

Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis

United States14 participantsStarted 2016-12-14

Plain-language summary

This observational study is designed to provide a better understanding of the potential use of interferon gamma (IFNγ) and IFNγ-inducible chemokines as markers of HLH disease activity in adults, and the potential of IFNγ to represent a therapeutic target.

Who can participate

Age range

18 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: * Patients \>=18 years old diagnosed with active HLH as established by the treating physician. * HLH forms of unknown origin or secondary to infections or rheumatologic disorders. * Should the diagnosis of primary HLH or malignancy become apparent after inclusion, the data collected will be analyzed separately as additional cohorts. * The patient must have consented to the use of their clinical data for research purposes at the site. Exclusion Criteria: * Patients with primary HLH (diagnosed by the presence of homozygous mutations in a known HLH causative gene) and secondary HLH due to malignancy are excluded.

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

Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Neopterin

Timeframe: 11 months

Trial details

NCT IDNCT06047210

SponsorSwedish Orphan Biovitrum

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-10-30

Results submitted2023-10-10

View on ClinicalTrials.gov More Hemophagocytic Lymphohistiocytoses trials

Who can participate

Age range

18 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.

What they're measuring

Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 10 (CXCL10)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - C-X-C Chemokine Ligand 9 (CXCL9)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interferon Gamma (IFNg)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 10 (IL-10)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 1 Beta (IL-1B)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Interleukin 6 (IL-6)

Timeframe: 11 months

Mean Serum Concentration of Inflammatory Biomarker - Neopterin

Timeframe: 11 months