Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05531721
Other study ID # HLH-OIRM
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 10, 2022
Est. completion date April 30, 2023

Study information

Verified date May 2023
Source Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Monocentric, observational, retrospective, no profit study aimed to analyze factors that are significantly impacting the outcome of patients diagnosed with HLH.


Description:

retrospective data collection to study: type of HLH familial vs secondary, sex, age, presence of infectious cause, involvement central nervous system ( SNC), hepatic involvement, presence of hemophagocytosis, presence of splenomegaly, presence of involvement of other organs, the value of neutrophils (PMN), the value of hemoglobin, platelets, albumin, triglycerides, ferritin, LDH, type of therapy and the response to therapy after 2 months


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date April 30, 2023
Est. primary completion date February 24, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Have received HLH diagnosis according to HLH 2004 criteria - age ?18 years. - followed at our facility between January 2004 and December 2021 - Whose parents have consented to participation and data processing Exclusion Criteria: - The study does not foresee specific exclusion criteria other than the non-compliance with the inclusion criteria

Study Design


Related Conditions & MeSH terms

  • Hemophagocytic Lymphohistiocytoses
  • Lymphohistiocytosis, Hemophagocytic

Intervention

Other:
Observation
Observation and retrospective data collection

Locations

Country Name City State
Italy AOU Città della Salute e della Scienza di Torino - Presidio Infantile Regina Margherita Turin

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant'Anna

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary physiological parameter that are significantly impacting the outcome of patients diagnosed with HLH Type of HLH (familial vs secondary); sex (M or F); age (in year); presence of infectious cause; involvement central nervous system (yes or no); hepatic involvement (yes or no); presence of hemophagocytosis (yes or no); presence of splenomegaly (yes or no); involvement of other organs (yes or no); value of neutrophils (PMN, in 10^9/L), hemoglobin (in g/dL), platelets (in 10^9/L), albumin (in g/L), triglycerides (in mg/dL), ferritin (in UI/L) and LDH (in UI/L); through study completion, an average of 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05491304 - Cytokine Guided Risk Stratification and Treatment in Pediatric Hemophagocytic Lymphohistiocytosis Phase 4
Not yet recruiting NCT05600959 - Sensitivity and Specificity of Cytokines in the Diagnosis of Lymphoma-associated HLH
Completed NCT03546101 - Early Detection of Epstein-Barr Virus Related Disease.
Recruiting NCT05898477 - Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytosis
Recruiting NCT05882175 - Prospective Validation of the OHI Index
Recruiting NCT05146336 - CytOSorb TreatMent Of Critically Ill PatientS Registry
Not yet recruiting NCT04902807 - Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation
Terminated NCT03985423 - A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Emapalumab in Adult Patients With HLH Phase 2/Phase 3
Completed NCT03513328 - Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation Phase 1/Phase 2
Not yet recruiting NCT05677178 - Response Prediction in EBV-HLH Using Metabonomics Analysis
Recruiting NCT03117010 - Prospective Cohort for Adult Hemophagocytosis
Not yet recruiting NCT06160791 - Ruxolitinib With De-Intensified HLH-94 for the Treatment of Hemophagocytic Lymphohistiocytosis (HLH) Phase 2
Recruiting NCT05236764 - Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion N/A
Recruiting NCT05277272 - INTO-HLH: A Disease Registry for Patients With Hemophagocytic Lymphohistiocytosis (HLH)
Completed NCT06047210 - Evaluation of IFNγ and Inflammatory Mediators in Patients With Hemophagocytic Lymphohistiocytosis
Not yet recruiting NCT05988177 - Efficacy and Safety of Carrimycin Tablets in HLH Patients With Carbapenem-resistant Infections N/A