Splenectomy as a Treatment for Patient With Relapsed Haemophagocytic Lymphohistiocytosis of Unknown Etiology
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|ClinicalTrials.gov Identifier: NCT02862054|
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hemophagocytic Lymphohistiocytosis||Procedure: splenectomy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2017|
Splenectomy as a treatment for patient with relapsed haemophagocytic lymphohistiocytosis of unknown etiology
- Evaluation of treatment response [ Time Frame: Change from before and1,2,4,8,12 and 24 weeks after splenectomy ]
A complete response was defined as normalization of all of the quantifiable symptoms and laboratory markers of HLH, including levels of sCD25, ferritin, and triglyceride; hemoglobin; neutrophil counts; platelet counts; and alanine aminotransferase (ALT).
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%; for patients with an initial neutrophil count of<0.5 ×109/L, a response was defined as an increase by at least 100% to>0.5× 109/L; for patients with a neutrophil count of 0.5 to 2.0 × 109/L, an increase by at least 100% to >2.0 × 109/L was considered a response; and for patients with ALT >400 U/L, response was defined as an ALT decrease of at least 50%.
- Survival [ Time Frame: from the time patients received splenectomy up to 24 months or December 2018 ]
- Adverse events that are related to treatment [ Time Frame: through study completion, an average of 2 years ]Adverse events including infection, bleeding and so on.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862054
|Contact: jingshi wang, M.M.||firstname.lastname@example.org|
|beijing Friendship Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: jingshi wang, M.M. 86-13520280731 email@example.com|
|Principal Investigator:||zhao wang||Beijing Friendship Hospital|