beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
NCT Number: NCT07339345
This study aims to investigate the efficacy and safety of Golidocitinib(GO) monotherapy in the treatment of hemophagocytic lymphohistiocytosis.
Interested in participating?
Request Info14 year–70 year
All sexes
Interventional
Phase 2 / Phase 3
Beijing, Beijing Municipality, 100050, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administer the GO regimen to HLH patients who meet the inclusion criteria, specifically Golicitinib 150 mg once daily.
Time frame: Weeks 2, 4, 6, and 8 after the start of treatment
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, triglyceride, blood cell count, hemophagocytosis, and level of consciousness (if CNS HLH is present).
A partial response was defined as at least a 25% improvement in 2 or more quantifiable symptoms and laboratory markers as follows: sCD25 response was>1.5-fold decreased; ferritin and triglyceride decreased at least 25%; without blood transfusion: Neutrophils <500/ml must increase by 100% and be >500/ml; neutrophils 500-2000/ml must increase by 100% and return to normal.; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%.
No response is defined as not meeting the criteria for partial response.
Time frame: 30 days after the last dose is administered.
An adverse event is defined as an adverse medical condition (including worsening of a pre-existing condition) that occurs in a subject or clinical trial subject after receiving medication, regardless of whether it is causally related to the investigational drug.
Serious adverse events are defined as AEs that meet one or more of the following criteria during any study period: death; immediate threat to life; and hospitalization or prolongation of hospitalization.
Time frame: 1 year
Patient's HLH-related symptoms and auxiliary examination results
Contact information is provided by the study sponsor or research team.
Beijing Friendship Hospital
Other
Prospective Single-Arm Clinical Trial of Golidocitinib Monotherapy for Hemophagocytic Lymphohistiocytosis.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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