Therapeutic exploratory study of KCB-1B for patients with tibial shaft fracture

UMIN ID: UMIN000000847

Registered date:11/10/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Tibial shaft fracture
• Date of first enrollment: 2006/03/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Arm P:A biodegradable gelatin hydrogel carrier
Arm L:A total dosage of 800 microgram of KCB-1 in a biodegradable gelatin hydrogel carrier
Arm H:A total dosage of 2400 microgram of KCB-1 in a biodegradable gelatin hydrogel carrier

Outcome(s)

• Primary Outcome: 1)Bone union at 24 weeks after administration 2)Date of a bone union 3)Number and degree of adverse effects
• Secondary Outcome: 1)Secondary intervention 2)Date of start full-weight bearing 3)Tenderness or pain and period to disappearance of those 4)Aftereffect 5)Serum KCB-1 level 6)Serum anti-KCB-1B antibody

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Multi fragmentary fracture 2)Pathological fracture 3)Patients with other sites fracture affecting loading exercise 4)Osteoporosis 5)History or complication of malignancy 6)History of allergy to food or medicine which contain gelatine 7)History of allergy to protein preparation 8)History of anaphylactic shock or status asthmaticus 9)Received administration of other trial drugs within 24 weeks 10)Pregnant women, nursing mothers or possibly pregnant women 11)Complication of serious renal disorders,liver disorders,hematological disorders and circulatory system disorders

Related Information

• Primary Sponsor: Kaken Pharmaceutical Co.,Ltd.
• Source(s) of Monetary Support: Kaken Pharmaceutical Co.,Ltd.