NCT00459641撤回2 期
A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and Young Adults With Solitary Bone Cysts
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Radiographic images
研究概览
简要总结
This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects 6 - 16 years of age
- •Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:
- •Cyst fluid examination
- •Plain radiographs
- •Subjects with the following types of cysts:
- •Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
- •Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
- •Persistence of a cyst cavity despite repeated interventions
- •Subjects with bone cyst volumes < 30 mL
- •Subjects must be appropriately communicative to verbalise pain.
- •Subjects must be able to understand and be willing to comply with the protocol procedures.
- •Subjects who have provided written informed consent to participate in the study
- •The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.
排除标准
- •A history of/or presence of active cancer
- •Family history of retinoblastoma
- •Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
- •Possible presence of osteosarcoma or uncertain histology
- •Systemic or localised infection at time of surgery
- •Evidence of immune-suppression
- •Evidence of hypercalcemia
- •Cyst volume > 30 mL
- •Fracture present in the cortical bone surrounding the cyst
- •Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.
- •Suspected or known evidence of allergic reactions towards any of the components of I-040302
- •Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study
- •Pregnant or lactating females
- •Participation in another clinical trial within 3 months prior to trial start
研究组 & 干预措施
1
Experimental
I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
干预措施: I-040302 (Drug)
2
Active Comparator
Standard of care (bone marrow aspirate or steroids)
干预措施: Standard of Care (Other)
结局指标
主要结局
Radiographic images
时间窗: At 6 months and throughout the study
次要结局
- Blood parameters(At 6 months and throughout the study)
- Vital signs(At 6 months and throughout the study)
- Questionnaires of life questionnaire(At 6 months and throughout the study)
- Pharmacoeconomic evaluation(At 6 months and throughout the study)
研究者
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