Status:
UNKNOWN
Evaluate the Efficacy and Safety of PEG-rhG-CSF in Patients With Hemophagocytic Syndrome
Lead Sponsor:
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Collaborating Sponsors:
Beijing Friendship Hospital
Conditions:
Hemophagocytic Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Hemophagocytic syndrome (HPS), also known as hemophagocytic lymphohistiocytosis (HLH), is an immune mediated life-threatening disease. There is no uniform recommendation for salvage treatment of HLH. ...
Eligibility Criteria
Inclusion
- Inclusion criteria：
- Age ≥ 18 years old, ≤ 70 years old;
- Patients with hemophagocytic syndrome diagnosed by HLH-2004 diagnostic criteria;
- Patients who plan to receive rescue treatment or maintenance treatment;
- The expected survival time is more than 1 month;
- Patients sign informed consent form.
- Exclusion Criteria：
- Patients who have received bone marrow or hematopoietic stem cell transplantation in the past 3 months;
- Patients with brain metastases;
- Patients who are allergic to this product or other biological products derived from genetic engineering E. coli;
- People with mental or nervous system disorders who cannot cooperate;
- Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
- Researchers determine unsuited to participate in this trial.
Exclusion
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04500886
Start Date
August 1 2020
End Date
September 1 2022
Last Update
August 5 2020
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, China