NCT00459641

Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kuros Biosurgery AG · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bone Cysts

Interventions

Type	Name	Description
DRUG	I-040302	doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
OTHER	Standard of Care	Bone marrow aspirate or steroids

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-06-01
• Completion: 2019-07-01
• First posted: 2007-04-12
• Last updated: 2012-07-17