Low-dose IL-2 ( Interleukin-2) Treatment in Macrophage Activation Syndrome（MAS）
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|ClinicalTrials.gov Identifier: NCT02569463|
Recruitment Status : Unknown
Verified October 2015 by Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : October 6, 2015
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|Macrophage Activation Syndrome||Drug: Interleukin-2||Phase 1 Phase 2|
Autoimmune-associated macrophage activation syndrome (MAS), also known as secondary hemophagocytic lymphohistiocytosis (HLH), is a rapidly progressing life-threatening disease. VP16 (Etoposide) is a well-known standard therapy, but is associated with substantial adverse effects, especially myelosuppression and infections , while steroids and ciclosporin (CSA) are not always efficient in this disease.
The investigators hypothesized that low- dose IL-2 could be a novel therapy in MAS. This clinical study will test the efficacy and safety of low dose IL-2 treatment in MAS. The investigators perform a single-centre pilot trial with rhIL-2 in MAS. The investigators evaluate the effectiveness and safeness of low-dose IL-2 for MAS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficiency Study of Low-dose IL-2 Treatment in Macrophage Activation Syndrome|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: Low-does rhIL-2 therapy
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks
Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.
Other Name: Recombinant Human Interleukin-2
- Disease activity on the HScore (a Score for the Diagnosis of Reactive Hemophagocytic Syndrome) [ Time Frame: 1month ]Examination of the therapeutic effects (improvement in HScore) of low dose IL-2 in patients with MAS
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): NCT02569463
|Contact: Jing He, MDfirstname.lastname@example.org|
|Department of Rheumatology and Immunology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100044|
|Contact: Jing He, MD, PhD +8618611707347 email@example.com|
|Principal Investigator:||Zhanguo Li||Department of Rheumatology and Immunology,Peking University People's Hospital|