EUCTR2011-000241-21-DE进行中（未招募）不适用
A clinical and mechanistic proof of efficacy study with belimumab in chronic immune thrombocytopenia (ITP) patients
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •A subject will be eligible for inclusion in this study only if all of the following criteriaapply:
- •1. Age & Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- •2. Disease severity: Diagnosis of chronic ITP for a minimum of 6 months (12 months for Germany) with a platelet count of <=75,000/µL (<=50,000/µL for Germany) at screening and a historical platelet count of <=75,000/µL (<=50,000/µL for Germany) 2 to 6 months prior to screening.
- •3. Platelet autoantibody status: Subjects with platelet auto-antibody +ve by MAIPA. Subsequently, if decision is made after one of the 2 planned interim analyses, subjects with platelet auto-antibody +ve by PIFT (i.e. MAIPA –ve, PIFT +ve). Following a separate decision after one of the 2 planned interim analyses, autoantibody negative subjects (MAIPA –ve, PIFT –ve) may be recruited into a separate open-labelled belimumab cohort.
- •4. ITP Treatment: ITP patients stable either on no treatment or on a stable dose of corticosteroids (10 mg/day prednisone or prednisone equivalent or less) and/or AZA
- •(100mg/day or less) or on MMF (2 g/day or less) for a minimum of 30 days before screening.
- •5. ECG: Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- •6. Female Subjects: A female subject is eligible to participate if she is not pregnant or nursing and at least one of the following conditions apply: a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12
- •months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study
- •enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status,
- •they can resume use of HRT during the study without use of a contraceptive method.
- •b. Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1.1 for one month (2 weeks for abstinence) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.
- •Female subjects must agree to use contraception until 16 weeks after the last dose.
- •7. Informed Consent: Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Secondary ITP: If the diagnosis of ITP is secondary to other conditions.
- •2. B-cell Prior Therapy: Have received treatment with any B cell targeted therapy at any time.
- •3. 364 Day Prior Therapy: Have received any of the following within 364 days prior to Day 0:
- •Abatacept.
- •A biologic investigational agent other than B cell targeted therapy.
- •4. 180 Day Prior Therapy: Have received any of the following within 180 days prior to Day 0:
- •Intravenous (IV) cyclophosphamide.
- •3 or more courses of systemic corticosteroids for concomitant conditions (eg, asthma, atopic dermatitis. Topical or inhaled steroids are permitted).
- •5. 90 Day Prior Therapy: Have received any of the following within 90 days prior to Day 0:
- •High dose corticosteroid for treatment of ITP (> 100 mg/day prednisone or equivalent).
- •Splenectomy, plasmapheresis.
- •6. 60 Day Prior Therapy: Have received any of the following within 60 days, 5 halflives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to Day 0:
- •A non-biologic investigational agent.
- •Any other immunosuppressive/immunomodulatory agent (e,g, ciclosporin A, dapsone, vincristine) with the exception of AZA, corticosteroids and MMF.
- •Eltrombopag, romiplostim.
- •Any steroid injection (intramuscular, intraarticular or intravenous).
- •Note: Inhaled steroids and Topical immunosuppressive agents (e.g. eye drops, topical creams) are allowed.
- •7. 30 Day Prior to Screening Therapy: Have received any of the following within 30 days prior to Screening:
- •Intravenous immunoglobulin.
- •Corticosteroids greater than 10mg/day or azathioprine more than 100 mg/day.
- •Changes to corticosteroid or azathioprine therapy or MMF therapy.
- •8. 30 Day Prior Therapy: Have received any of the following within 30 days prior to Day 0:
- •A live vaccine.
- •9. Haemorrhage: Disease status where, in the opinion of the investigator, the subject could be at risk of haemorrhage that threatens a vital organ.
- •10. Transplantation: Have a history of a major organ transplant or hematopoietic stem cell/marrow transplant.
- •11. Cancer: Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin or carcinoma in situ of the uterine cervix.
- •12. Acute or chronic infection: Have required management of acute or chronic infections, as follows:
- •Currently on any suppressive therapy for a chronic infection
- •Hospitalisation for treatment of infection within 60 days prior to Day 0.
- •Use of parenteral antibiotics within 60 days prior to Day 0.
- •13. Other diseases/conditions: Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to ITP which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk. or Have a planned surgical procedure or a history of any other medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, makes the subject unsuitable for the study.
- •14. Hepatitis: A positive screening Hepatitis C antibody result or serologic evidence of Hepatitis B (HB) infection based on the results of testing for HBsAg, anti-HBc and anti-HBs as follows:
- •Patients positive for HBsAg are excluded.
- •Patients negative for HBsAg and anti-HBc antibody but positive for anti-HBs antibody and with no history of Hepatitis B vaccination are excluded.
- •Patients negative for HBsAg but positive for both anti-HBc an
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