Safety, tolerability, blood levels and efficacy of a single dose of Osteogrow ( which is made of a protein called recombinant human bone metamorphic protein 6 which is delivered in a carrier made from the patients own blood ) injected into the fracture site in adult patients with a fracture of the wrist.

Phase 1

• Conditions: Distal radius fracture.; MedDRA version: 20.0 Level: PT Classification code 10048049 Term: Wrist fracture System Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2014-005101-21-HR
• Lead Sponsor: Genera Research Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-26
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients meeting ALL of the following criteria at screening will be eligible for participation in the study:
1.Willing and able to provide informed consent. A signed informed consent form must be provided before any study assessments are done. Patients must be fluent in the language that is spoken by the investigator and the trial staff and in which the informed consent is written.
2.Male or female, age =18 years.
3.Current diagnosis of unilateral dorsally angulated closed fracture of the distal radius within the past 72 hours needing reduction and stabilization by Kirschner wires, but no open surgery.
4.Otherwise healthy as defined by absence of clinically relevant abnormalities identified by a detailed medical history, full physical examination (including vital signs), 12-lead ECG, and clinical laboratory tests.
5.Willing and able to be confined to the hospital/inpatient unit for at least 48h postoperatively and to comply with all other follow-up procedures according to protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

Patients meeting ANY of the following criteria at screening will NOT be eligible for participation in the study:
1.Previous fracture or bone surgery in the currently fractured distal forearm.
2.Joint diseases that affect the function of the wrist and/or hand of the injured arm.
3.Previous treatment with bone morphogenic proteins (e.g. Ossigraft).
4.Evidence or history of clinically significant hepatic disease (>3 x ULN for AST/ALT and total bilirubin) or other abnormalities in screening laboratory tests, which in the judgment of the investigator, would interfere with the patient’s participation in the study.
5.Presence or history of an uncontrolled, unstable, clinically significant medical condition (renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease or malignancy) that in the judgment of the investigator may interfere with the interpretation of safety and PK evaluations.
6.Other clinically significant systemic or bone metabolic disease
7.History of symptomatic nephro- or urolithiasis within two years.
8.History of diabetes mellitus.
9.Treatment with an investigational drug within 6 months or 5 half-lives (whichever is longer) preceding the first dose of study medication.
10.Screening 12-lead ECG demonstrating at least 1 of the following: Heart rate >100 bpm, QRS >120 msec, QTc > 430 msec (males), QTc >450 msec (females), or PR interval >220 msec.
11.Breastfeeding a child or planning to become pregnant within 6 months.
12.Use of corticosteroids within 7 days prior to surgery and postoperative for the duration of the study.
13.Known serological evidence of human immunodeficiency virus (HIV) antibody.
14.History of hepatitis B infection within the past year or history of inadequately treated hepatitis C infection.
15.Known drug or alcohol abuse.
16.Donation of blood in excess of 500 mL within 56 days prior to and 1 month following surgery.
17.Current participation in any other clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified