EUCTR2005-001290-10-DE进行中（未招募）不适用
A study to provide expanded access of EXJADE® (deferasirox) to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with other locally approved iron chelators
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
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
- •Of either sex and aged 2 years or older
- •Documented congenital disorder of red blood cells requiring ongoing blood transfusions
- •Patients that cannot be adequately treated with a locally approved iron chelator due to one of the following reasons: Documented non-compliance; Contraindications, unacceptable toxicities and/or documented poor response to locally approved iron chelators, despite proper compliance;
- •History of at least 20 blood transfusions (equivalent to 100 mL/kg of PRBC)
- •Serum ferritin value greater than or equal to 1000 µg/L
- •Ability to comply with all study-related procedures, medications, and evaluations
- •Written informed consent by the patient or for pediatric patients consent of the patient’s legal guardian.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Ongoing treatment with another iron chelator
- •Eligibility for any other ongoing Novartis sponsored clinical study protocol with EXJADE® and geographic access to these sites
- •Galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption
- •Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with EXJADE®
- •Serum creatinine above the upper limit of normal within one week prior to baseline
- •Significant proteinuria as indicated by a urinary protein/creatinine ratio= 0.5 (mg/mg) in a non-first void urine sample within one week prior to baseline, or alternatively a urinary protein/creatinine ratio = 0.5 (mg/mg) in two of three samples obtained
- •ALT =500 U/L within one week prior to baseline
- •Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
- •Pregnancy and patients who are breastfeeding
- •Patients treated with systemic investigational drug within 4 weeks prior to or with topical investigational drug within 7 days prior to the baseline visit
研究者
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