EUCTR2005-001290-10-GR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
- •Male or female patients greater than or equal to 2 years of age.
- •Documented congenital disorder of red blood cells (e.g., ß-thalassemia major, sickle cell anemia, diamond-blackfan anemia) 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, defined as having taken less than 50% of the prescribed chelation therapy doses in the 12 months prior to study entry
- •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 at screening
- •Ability to comply with all study-related procedures, medications, and evaluations
- •Sexually active pre-menopausal female patients must use double-barrier contraception, oral contraceptive plus barrier contraceptive, or must have undergone clinically documented total hysterectomy and/or oophorectomy, tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
- •Written informed consent by the patient or for pediatric patients consent of the patient’s legal guardian. The definition of the term ‘pediatric’ for enrollment and study conduct will be in accordance with local legislation. Parents or the legal guardians will be fully informed by the investigator as to the requirements of the study. Pediatric patients themselves will be informed according to their capabilities in a language and in terms that they are able to understand. Written informed consent will be obtained from their legal guardian on the patient’s behalf in accordance with national legislation. If capable, all pediatric patients should also personally sign their written informed assent.
- •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 (any other iron chelation therapy must be discontinued at least 24 hours prior to study entry)
- •Patients who meet the eligibility criteria for any other ongoing Novartis sponsored clinical study protocol with Exjade and who have geographic access to these sites
- •Patients unable to tolerate (or who have unacceptable toxicities to) prior treatment with Exjade
- •Serum creatinine above the upper limit of normal at screening
- •Patients with ALT =500 U/L at screening
- •Evidence of chelation-related cataracts or hearing loss within 4 weeks prior to baseline
- •Pregnancy (as indicated by serum ß-HCG pregnancy test at screening for all female patients with the potential to become pregnant) 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
- •Patients who are found to be ineligible after screening procedures will have this
- •documented in a screening log CRF. These patients will not need to complete the end of study assessments.
研究者
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