EUCTR2011-006322-25-GB进行中（未招募）1 期
A Phase 2, Open-label, Multicentre, Extension Safety and Tolerability Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using SSP-004184 (SPD602).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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
- •For all subjects:
- •1. Subjects and/or parents willing and able to sign the approved informed consent/and assent (based on institutional guidelines).
- •2. An understanding, ability, and willingness to fully comply with study procedures and restrictions.
- •3. Has either completed a previous SSP-004184AQ study or prematurely discontinued (with agreement from the Investigator and Shire physician) from 1 of the SSP-004184AQ studies.
- •4. If applicable, female subjects should be either:
- •Post-menopausal (12 consecutive months of spontaneous amenorrhea), or
- •Surgically sterile, or
- •Females of child-bearing potential must have a negative urine pregnancy test at the Qualification and Enrollment Visit prior to dosing on Day 1. Females of child-bearing potential must agree to abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception
- •For subjects that did not transition directly from their feeder protocol and have initiated treatment with a chelator other than SSP-004184AQ:
- •5. Willing to discontinue all existing iron chelation therapies for a minimum period of 1 to 5 days prior to first dose of SSP-004184AQ.
- •6. (Note: This inclusion criterion is also applicable for subjects that were receiving chelators other than SSP-004184AQ in their feeder protocol.)
- •7. Serum ferritin >500 ng/mL at the Qualification and Enrollment Visit.
- •8. Liver iron concentration (LIC) =2.0 mg iron per g (equivalent dry weight, liver) determined by FerriScan® R2 MRI at the Qualification and Enrollment Visit (Day -28 to Day -8). (Note: Younger subjects for whom MRI is not feasible will be considered iron overloaded on the basis of serum ferritin only.)
- •9. Mean of the previous 3 pre-transfusion hemoglobin concentrations =7.5 g/dL
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •For all subjects:
- •1. Unwilling to remain off all other existing chelation therapies during SSP-004184AQ dosing and for up to 24 hours from last dose.
- •2. A history of non-compliance in a prior FerroKin/Shire-sponsored SSP-004184AQ study (excluding dose suspensions that were medically warranted).
- •3. Cardiac MRI T2* <10.0 milliseconds at the Qualification and Enrollment Visit.
- •4. Cardiac left ventricular ejection fraction <50% at the Qualification and Enrollment Visit by MRI or below the locally determined normal range by echocardiography if MRI information is not available.
- •5. Evidence of clinically relevant oral, cardiovascular, gastrointestinal, endocrine, pulmonary, neurologic, psychiatric, immunologic, bone marrow, dermatologic, hepatic, biliary (eg, chronic cholecystitis), or renal dysfunction where, in the opinion of the Investigator or the Shire Study Physician, treatment with SSP-004184AQ is relatively contraindicated.
- •6. Platelet count below 100,000/µL or absolute neutrophil count less than 1500/mm3 at the Qualification and Enrollment Visit.
- •7. Known sensitivity to any ingredient in the SSP-004184AQ formulation.
- •8. Pregnant or lactating females.
- •For subjects that did not transition directly from their feeder protocol and have initiated treatment with a chelator other than SSP-004184AQ:
- •9. In younger subjects for whom MRI is not feasible, evidence of severe cardiac dysfunction, as assessed by the Investigator.
- •10. Non-elective hospitalization within the 30 days prior to receiving the first dose of SSP 004184AQ.
- •11. For subjects =18 years old: ALT >200 IU/L at the Qualification and Enrollment Visit.
- •For subjects <18 years old: ALT >180 IU/L at the Qualification and Enrollment Visit.
- •12. For subjects =18 years old: Evidence of severe renal insufficiency, eg, serum creatinine 1.5X above the upper limit of normal or proteinuria greater than 1 gm per day or a calculated glomerular filtration rate <40 mL/min.
- •For subjects <18 years old: Evidence of significant renal insufficiency, eg, serum creatinine above the upper limit of normal or proteinuria greater than 1 gm per day.
- •13. Use of any investigational agent within the 30 days prior to receiving the first dose of SSP-004184AQ.
- •14. Cardiac left ventricular ejection fraction below the locally determined normal range in the 12 months prior to Screening by
- •echocardiography or MRI or <50% at Baseline testing by MRI (Echocardiograph is acceptable for LVEF if MRI information is not available.
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