EUCTR2016-002529-12-DE进行中（未招募）1 期
A phase II, multicenter, open-label, randomized two-year study to evaluate the efficacy and safety of deferasirox film-coated tablet versus phlebotomy in patients with Hereditary Hemochromatosis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •- Male or female = 18-years-old
- •- Documented genotype testing confirming homozygous for the C282Y mutation (C282Y/C282Y)
- •- Transferrin saturation = 45% (at either screening visit)
- •- Serum Ferritin = 700 µg/L (at either screening visit)
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. Medical conditions that preclude inclusion:
- •- Iron overload not due to HH
- •- Condition which might significantly alter the absorption, distribution, metabolism or excretion of oral deferasirox
- •- Systemic disease which prevents taking study treatment or any contraindication to phlebotomy
- •- Inflammatory condition or immunological disease which may interfere with the SF interpretation, such as an active infection, collagen vascular disorders, irritable bowel syndrome, lupus, or immune thrombocytopenia
- •- Significantly impaired gastrointestinal function or disease that may significantly alter the absorption of oral deferasirox, e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption
- •2. Prior iron chelation therapy, prohibited concomitant medications with deferasirox
- •syndrome, or small bowel resection.
- •- Psychiatric or addictive disorder which prevent giving informed consent or undergoing any of the treatment options or unwilling or unable to comply with the protocol
- •- Uncontrolled or significant cardiac disease or symptomatic cardiac arrhythmias, e.g., sustained ventricular tachycardia and clinically significant second or third degree AV block without a pacemaker
- •- Illicit drug use and/or alcohol use, defined as an average alcohol consumption greater than one standard drink a day for women or two standard drinks a day for men within the 12 months prior to enrolment.
- •- Cirrhosis, including Child-Pugh class A, B, and C, diagnosed by liver biopsy, elastography, radiologic exams, or clinical criteria.
- •- Active hepatitis B or C (hepatitis B carrier will be allowed)
- •- History of HIV seropositivity (ELISA or Western blot)
- •- Malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, except localized basal cell carcinoma of the skin, or any history of hepatocellular carcinoma
- •3. Abnormal laboratory values
- •4. Participation in an investigational study:
- •- Observational registry study is allowable
- •- Within 30 days prior to enrollment or within 5-half-lives of an investigational product, whichever is longer
- •- Treatment with a systemic investigational drug within 4 weeks or topical investigational drug within 7 days of starting the study
- •5. Pregnancy and contraception:
- •- Pregnant or nursing (lactating) women
- •- Women of child-bearing potential unless using basic methods of contraception
- •- Post-menopausal and not of childbearing potential if she has had 12 months of natural (spontaneous) amenorrhea with an expected clinical profile
研究者
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