EUCTR2015-001327-23-IT进行中（未招募）1 期
Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study
Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'Adulto0 个研究点目标入组 52 人开始时间: 2015年4月29日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- •1.Diagnosis of primary ITP;
- •2.Age = 18 years;
- •3.Patients are in the new diagnosis or persistent phase of disease (i.e. within month 12 from diagnosis);
- •4.Patients not responsive or in relapse after a full course of steroid therapy (prednisone 1 mg/kg/d for at least 28 days or 3 cycles of dexamethasone 40 mg/day for consecutive 4 days, according to the GIMEMA ITP0207 trial) ± IVIG;
- •5.Patients have a platelet count < 10 x 109/L documented in a single blood cell count;
- •Patients have bleeding symptoms and a platelet count > 10 < 30 x 109/L documented in a single blood cell count; OR
- •Patients have no bleeding symptoms and a platelet count >10 < 30 x 109/L in at least 2 blood cell counts at 3 days interval in the week preceding the enrolment with the last count at the day of enrolment;
- •Patients have corticosteroids or IVIG dependence (the need for ongoing or repeated doses administration of corticosteroids or IVIG to maintain a platelet count = 30 x 109/L and/or to avoid bleeding;
- •6.Written informed consent obtained from the subject;
- •7.Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of enrolment randomization until 6 months after the last dose of study treatment;
- •8.Female subjects of non-childbearing potential may be enrolled in the study; for this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause;
- •Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to start of Eltrombopag, has a negative pregnancy test within 14 days of first dose of Eltrombopag, and has agreed to continue adequate contraception during the entire treatment period and for 6 months after completion of the treatment.;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Diagnosis of secondary ITP. As far as patients with immune thrombocytopenia and antiphospholipid antibodies positivity, individuals without a previous thromboembolic event are excluded only if lupus anticoagulant (LAC) is associated with the presence of anticardiolipin (aCL) and aß2-Glycoprotein I (aß2GPI) antibodies (triple positivity according to Pengo et al. Blood 2011) (10);
- •2.Previous treatment with other anti-ITP second line therapies (i.e. Rituximab, Azathioprine, Cyclosporin-A or other); only patients with a previous full course of steroid (see inclusion criteria for definition) ± IVIG are admitted to the study;
- •3.Previous treatment with any TPO-R agonists;
- •4.Patients have life threatening bleeding complications;
- •5.Patients had deep venous thrombosis (DVT) or arterial thrombosis in the 3 months preceding the enrolment;
- •6.Patients are HIV, HCV, HBsAg positive;
- •7.Patients with hepatic impairment (i.e. mild, moderate or severe hepatic impairment (Child-Pugh score > 6);
- •8.Patients have a well established liver disease that represents a contraindication for the use of Eltrombopag;
- •9.Patients are unable to respect the 4-hour interval between Eltrombopag and other medications (e.g. antacids), calcium-rich foods (e.g. dairy products and calcium fortified juices), or supplements containing polyvalent cations such as iron, calcium, aluminium, magnesium, selenium, and zinc;
- •10.Patients are unable to stop medications that are known to cause a drug-drug interaction with Eltrombopag;
- •11.Subjects meeting any of the following criteria must not be enrolled in an Eltrombopag study:
- •a)Lactating female.
- •b)History of another malignancy. Exception: subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.
- •c)Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures.
- •d)Hormone replacement therapy. Subjects must discontinue hormone replacement therapy prior to study enrolment due to the potential for inhibition of Cytochrome P450 (CYP) enzymes that metabolize estrogens and progestins.
- •e)Administration of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
- •f)Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to Eltrombopag or excipients that contraindicate their participation.
研究者
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