EUCTR2016-001406-42-DK进行中（未招募）1 期
Statin- and bisphosphonate treatment in patients with the Philadelphia-negative chronic myeloproliferative neoplasms - essential thrombocytosis, polycythemia vera and hypercellular myelofibrosis.
Hæmatologisk Afdeling, Sjælland Sygehus, Roskilde0 个研究点目标入组 100 人开始时间: 2016年4月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- •Low-risk MPN patients
- •1.WHO 2016 classified ET, PV or hyperproliferativ primary myelofibrosis og prePMF (thrombocytosis and/or leukocytosis without anemia).
- •2.Age > 18 years.
- •3.Expected survival > 1 year.
- •4.Fulfills criteria for low-risk MPN disease:
- •a.Age < 60 years and
- •b.No prior thrombosis and
- •c.B-thrombocytes < 1500 x 109/l.
- •5.Does not use statin or bisphosphonate.
- •High-risk MPN patients
- •1.WHO 2008 classified ET, PV or hyperproliferativ primary myelofibrosis (thrombocytosis and/or leukocytosis without anemia).
- •2.Age > 18 years.
- •3.Expected survival > 1 year.
- •4.Fulfills criteria for high-risk MPN disease:
- •a.Age > 60 years or
- •b.Prior thrombosis or
- •c.B-thrombocytes > 1500 x 109/l.
- •5.Does not use statin or bisphosphonate.
- •Reactive thrombocytosis and/or leukocytosis
- •1.Referred on suspicion of MPNs. No suspicion of MPN disease.
- •2.Age > 18 years.
- •3.Expected survival > 1 year.
- •4.Does not use statin.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Uncontrolled autoimmune or chronic inflammatory disease
- •2.Different active cancer
- •3.Pregnancy (in fertile women pregnancy must be ruled out by negative pregnancy test and safe contraceptive treatment must be used).
- •Low-risk MPN:
- •1.Contraindications against atorvastatin treatment
- •a.Active lever disease or continuous elevated transaminases of unknown reasons
- •b.Use of potent CYP3A4-inhibitors
- •c.Use of gemfibrozil or ciclosporin
- •d.Allergies against statins
- •2.Contraindications against zoledronic acid treatment
- •a.Severe renal failure (GFR < 35 ml/min/1,73m2)
- •b.Allergies against bisphosphonates
- •High-risk MPN:
- •1.Contraindications against atorvastatin treatment.
- •a.Active lever disease or continuous elevated transaminases of unknown reasons
- •b.Use of potent CYP3A4-inhibitors
- •c.Use of gemfibrozil or ciclosporin
- •d.Allergies against statins
- •2.Contraindications against zoledronic acid treatment
- •a.Severe renal failure (GFR < 35 ml/min/1,73m2)
- •b.Allergies against bisphosphonates
- •3.Contraindications against interferon treatment
- •a.Uncompensated lever cirrhosis, severely reduced lever function along with HIV-HCV infected patients with cirrhosis and Child-pugh > 6
- •b.Severe cardiac disease
- •c.Autoimmune hepatitis
- •d.Abnormal TSH (must be corrected)
- •e.Allergies against interferon
- •Reactive thrombocytosis and/or leukocytosis
- •1.Contraindications against atorvastatin treatment
- •a.Active lever disease or continuous elevated transaminases of unknown reasons
- •b.Use of potent CYP3A4-inhibitors
- •c.Use of gemfibrozil or ciclosporin
- •d.Allergies against statins
研究者
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