Low-dose Baricitinib Plus Danazol for Steroid-resistant/Relapse Immune Thrombocytopenia
NCT ID: NCT05852847
Last Updated: 2023-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
216 participants
INTERVENTIONAL
2023-05-16
2025-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-dose baricitinib plus 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.
Baricitinib 2 MG [Olumiant]
Oral baricitinib was given at a dose of 2 mg daily for 6 months. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Danazol
Danazol was given at a dose of 200 mg bid for 6 months
Danazol
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
Danazol was given at a dose of 200 mg bid for 6 months
Interventions
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Baricitinib 2 MG [Olumiant]
Oral baricitinib was given at a dose of 2 mg daily for 6 months. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Danazol
Danazol was given at a dose of 200 mg bid for 6 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with chronic low platelet count (\<30,000/μL) for 6 months who have failed at least one treatment for chronic low platelet count;
3. 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;
4. Patients with a platelet count \<30,000/μL or a platelet count \<50,000/μL with clinically significant bleeding symptoms at the enrollment;
5. Willing and able to provide written informed consent, and agreeable to the schedule of assessment.
Exclusion Criteria
2. Active or a history of malignancy;
3. Pregnancy or lactation;
4. Current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
5. A history of symptomatic herpes zoster infection within 12 weeks prior to screening;
6. Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
7. 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;
8. 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;
9. Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
10. 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;
11. 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.
18 Years
70 Years
ALL
No
Sponsors
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Beijing Luhe Hospital
OTHER
Chinese PLA General Hospital
OTHER
Navy General Hospital, Beijing
OTHER
Beijing Hospital
OTHER_GOV
Beijing Friendship Hospital
OTHER
Peking University First Hospital
OTHER
Peking University Third Hospital
OTHER
China-Japan Friendship Hospital
OTHER
Beijing Tsinghua Changgeng Hospital
OTHER
Peking University People's Hospital
OTHER
Responsible Party
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Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Principal Investigators
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Xiaohui Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University Institute of Hematology, Peking University People's Hospital
Locations
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Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, , China
Beijing Hospital
Beijing, , China
Beijing Luhe Hospital
Beijing, , China
Beijing Tsinghua Changgeng Hospital
Beijing, , China
China-Japan Friendship Hospital
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
Peking University First Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
The Sixth Medical Center of PLA General Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PKU-BAITP-01
Identifier Type: -
Identifier Source: org_study_id
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