Low-dose Baricitinib Plus High-dose Dexamethasone for Patients With Newly Diagnosed Immune Thrombocytopenia
NCT ID: NCT05932524
Last Updated: 2023-07-12
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
132 participants
INTERVENTIONAL
2023-07-07
2025-06-30
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 high-dose dexamethasone
Oral baricitinib is given at a dose of 2 mg daily for 6 consecutive months. Dexamethasone is administrated at 40 mg per day for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10). Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Baricitinib 2 MG
Baricitinib 2 mg q.d., p.o., for 6 consecutive months.
Dexamethasone
Dexamethasone 40 mg q.d. for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10)
High-dose dexamethasone
Dexamethasone is administrated at 40 mg per day for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10). Treatment will be discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Dexamethasone
Dexamethasone 40 mg q.d. for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10)
Interventions
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Baricitinib 2 MG
Baricitinib 2 mg q.d., p.o., for 6 consecutive months.
Dexamethasone
Dexamethasone 40 mg q.d. for 4 consecutive days (the 4-day course of dexamethasone will be repeated in the case of lack of response by day 10)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. A platelet count \<30,000/μL, or a platelet count \<50,000/μL with clinically significant bleeding symptoms (WHO bleeding scale 2 or above) at the enrollment;
3. Willing and able to sign written informed consent.
Exclusion Criteria
2. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
3. Active or a history of malignancy;
4. Pregnancy or lactation;
5. Received first-line and second-line ITP-modifying therapy;
6. Previously received corticosteroids or immunosuppressive agents for non-ITP diseases within 6 months before enrollment;
7. A history of clinically significant adverse reactions to previous corticosteroid therapy;
8. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
9. Current or recent (\<4 weeks prior to screening) clinically serious viral, bacterial, fungal, or parasitic infection;
10. A history of symptomatic herpes zoster infection within 12 weeks prior to screening;
11. Active or chronic viral infection from hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV);
12. 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;
13. 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;
14. Myocardial infarction (MI), unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
15. 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;
16. 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
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, , 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-03
Identifier Type: -
Identifier Source: org_study_id
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