CTRI/2017/10/010252进行中（未招募）2 期
randomized, open-label, multicenter, two arm, phase IIstudy to evaluate treatment compliance, efficacy and safetyof an improved deferasirox formulation (granules) inpediatric patients with iron overload
ovartis Healthcare Private Limited0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Written informed consent/assent before any study-specific procedures.
- •2. Consent will be obtained from parent(s) or legal guardians. Investigators will also
- •obtain assent of patients according to local guidelines.
- •3. Male and female children and adolescents aged between 2 and 18 years.
- •Applicable to core phase only. Once in the core phase patients can turn 18 years
- •and still be considered eligible, also for participation in the optional extension
- •4. Any transfusion-dependent anemia associated with iron overload requiring iron
- •chelation therapy and with a history of transfusion of approximately 20 PRBC units,
- •and a treatment goal of reduction, not maintenance of iron burden as measured by
- •serum ferritin.
- •5. Serum ferritin > 1000 ng/mL, measured at screening Visit 1 and screening Visit
- •2 (the mean value will be used for eligibility criteria).
- •6. Completion of core phase per protocol (For the optional extension phase
- •criteria only).
- •7. Meeting inclusion criteria as defined in the core phase at Visit 17 except for age
- •requirement (For the optional extension phase criteria only).
排除标准
- •1. Creatinine clearance below the contraindication limit in the locally approved
- •prescribing informationCreatinine clearance will be estimated from serum creatinine (using the Schwartz formula) at screening Visit 1 or screening Visit 2.
- •2. Serum creatinine > 1.5 xULN at screening Visit 1 or screening Visit 2.
- •3. ALT or AST greater than 3.0 x ULN at screening visit 1 or screening visit 2.
- •4. Liver disease with severity of Child-Pugh class B or C.
- •5. Significant proteinuria as indicated by a urinary protein/creatinine ratio >0.5 mg/mg in a second morning urine sample at screening Visit 1 or screening Visit 2.
- •6. Patients with significant impaired gastrointestinal (GI) function or GI disease
- •that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- •7. Clinical or laboratory evidence of active Hepatitis B or Hepatitis C (HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive).
- •8. Patients with psychiatric or addictive disorders which prevent them from giving
- •their informed consent/assent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol (including use of electronic devices for ePRO).
- •9. Local access to new formulation (granules or FCT) is available for the patient
- •(For the optional extension phase criteria only).
- •10. Meeting any of the exclusion criteria as defined in the core phase (For the
- •optional extension phase criteria only).
研究者
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