Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia
Immune Thrombocytopenia
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, baricitinib
Eligibility Criteria
Inclusion Criteria: Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia; Patients with chronic low platelet count (<30,000/μL) for 6 months who have failed at least one treatment for chronic low platelet count; Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation; Patients with a platelet count <30,000/μL or a platelet count <50,000/μL with clinically significant bleeding symptoms at the enrollment; Willing and able to provide written informed consent, and agreeable to the schedule of assessment. Exclusion Criteria: Secondary immune thrombocytopenia (e.g. patients with HIV, HCV, Helicobacter pylori infection or patients with confirmed autoimmune disease); Active or a history of malignancy; Pregnancy or lactation; Current or recent (<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection; A history of symptomatic herpes zoster infection within 12 weeks prior to screening; Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); Have evidence of active tuberculosis (TB), or have previously had evidence of active TB and did not receive appropriate and documented treatment, or have had household contact with a person with active TB and did not receive appropriate and documented prophylaxis for TB; Have experienced a clinically significant thrombotic event within 24 weeks of screening or are on anticoagulants and in the opinion of the investigator are not well controlled; Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure; A history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data; Any of the following specific abnormalities on screening laboratory tests: 1) ALT or AST >2 x ULN, or total bilirubin ≥1.5 x ULN 2) hemoglobin <9 g/dL, or total white blood cell (WBC) count <2,500/µL, or neutropenia (absolute neutrophil count <1,200/µL), or lymphopenia (lymphocyte count <750/µL) 3) eGFR <50 mL/min/1.73 m^2.
Sites / Locations
- Peking University Insititute of Hematology, Peking University People's HospitalRecruiting
- Beijing Friendship HospitalRecruiting
- Beijing HospitalRecruiting
- Beijing Luhe HospitalRecruiting
- Beijing Tsinghua Changgeng HospitalRecruiting
- China-Japan Friendship HospitalRecruiting
- Chinese PLA General HospitalRecruiting
- Peking University First HospitalRecruiting
- Peking University Third HospitalRecruiting
- The Sixth Medical Center of PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low-dose baricitinib plus danazol
Danazol
Oral baricitinib is given at a dose of 2 mg daily for 6 months. Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Danazol is given at a dose of 200 mg twice a day for 6 months. Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.