Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia (BAITP)
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|ClinicalTrials.gov Identifier: NCT05446831|
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : September 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|ITP Immune Thrombocytopenia||Drug: Baricitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Baricitinib for Steroid-resistant/Relapse Immune Thrombocytopenia: A Single-arm, Open-label Phase II Study|
|Actual Study Start Date :||July 13, 2022|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||December 1, 2023|
Oral baricitinib was given at a dose of 4 mg daily for 6 months. Treatment was discontinued if very severe or life-threatening adverse events developed or at the patients' request.
Oral baricitinib was given at a dose of 4 mg daily. The decision to initiate rescue therapy was made after assessment of the extent of bleeding, patient preferences, lifestyle and activity, the complications of specific therapies, comorbidities that predisposed patients to bleeding and the tolerance of side effects. If a platelet count over 300,000/μL was observed for two consecutive tests at least 2 weeks apart, baricitinib treatment was interrupted.
- Durable response [ Time Frame: 6 months ]The maintenance of a platelet count ≥30,000/μL, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up.
- Complete response (CR) [ Time Frame: 1 month ]Complete response (CR) was defined as a platelet count over 100,000/μL and absence of bleeding.
- Response (R) [ Time Frame: 1 month ]Response (R) as a platelet count over 30,000/μL and at least 2-fold increase of the baseline count and absence of bleeding.
- Time to response [ Time Frame: 6 months ]The time from starting treatment to time of achievement of CR or R.
- Duration of response [ Time Frame: 6 months ]Duration of response at 6-month follow up.
- Early response [ Time Frame: 7 days ]Achievement of CR or R at day 7
- Initial response [ Time Frame: 28 days ]Achievement of CR or R at day 28
- Bleeding events [ Time Frame: From the start of study treatment (Day 1) to the end of week 24 ]Clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale.
- Health-related quality of life (HRQoL) [ Time Frame: From the start of study treatment (Day 1) to the end of week 24 ]ITP-PAQ is used to assess the Health Related Quality of Life (HRQoL) before and after treatment.
- Adverse events [ Time Frame: From the start of study treatment (Day 1) to the end of week 24 ]Adverse events (AEs) are reported and graded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Over 18 years old
- Willing and able to provide written informed consent, and agreeable to the schedule of assessment
- 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
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): NCT05446831
|Contact: Xiaohui Zhang, MDemail@example.com|
|Contact: Peng Zhao, MDfirstname.lastname@example.org|
|Peking University Insititute of Hematology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100010|
|Contact: Xiaohui Zhang, MD +8613522338836 email@example.com|
|Contact: Peng Zhao, MD +8618810323668 firstname.lastname@example.org|
|Principal Investigator: Xiaohui Zhang, MD|
|Principal Investigator:||Xiaohui Zhang, MD||Peking University People's Hospital|
|Responsible Party:||Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital|
|Other Study ID Numbers:||
|First Posted:||July 7, 2022 Key Record Dates|
|Last Update Posted:||September 28, 2022|
|Last Verified:||September 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders
Immune System Diseases