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

Phase 2

Completed

• Conditions: Tibial shaft fracture

• Registration Number: JPRN-UMIN000000847
• Lead Sponsor: Kaken Pharmaceutical Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-11
• Study Completion: 2009-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Bone union at 24 weeks after administration 2)Date of a bone union 3)Number and degree of adverse effects

Secondary Outcome Measures

Name	Time	Method
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