A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist

A Double-blind, Randomized, Placebo-controlled Phase 2b Study to Establish the Effective Dose Range and to Evaluate the Safety of Chrysalin in Adult Subjects With a Fractured Distal Radius

The purpose of this study is to evaluate the safety of Chrysalin, also known as TP508, and to determine the effectiveness of four doses of Chrysalin for treating broken wrists in adults.

Study Overview

• Status: Terminated
• Conditions: Radius Fracture
• Intervention / Treatment: Drug: Chrysalin; Drug: Chrysalin; Drug: Chrysalin; Drug: Chrysalin; Drug: Placebo

Detailed Description

There is a medical need for a product that is safe and can accelerate the rate of bone healing, leading to a reduction in immobilization time. Chrysalin, also known as TP508, is a synthetic peptide (protein) that is an exact copy of part of the human protein thrombin, which is a protein that occurs naturally in the body. Chrysalin can be used to mimic part of the thrombin response after injury without stimulating any of the events associated with blood clotting, and can therefore accelerate the normal process of healing.

• Study Type: Interventional
• Enrollment (Actual): 274
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85281
      • OrthoLogic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• An unstable and/or displaced fracture of the distal radius
• Fracture classified as primary intra-articular or extra-articular
• Male, or non-pregnant, non-lactating female at least 18 years old. If female of childbearing potential, must have confirmed negative pregnancy test prior to administration of study product. Must agree to use a medically approved method of birth control for 6 months.
• Need ability to understand study requirements, provide written informed consent, and comply with study protocol
• Need ability to understand and provide written authorization for use and disclosure of health information per Health Insurance Portability and Accountability Act (HIPAA)

Exclusion Criteria:

• History of distal radius fracture of the affected limb 2 years prior to study enrollment
• History of uncontrolled Type I or Type II diabetes mellitus
• History or clinical evidence of any active medical disease or condition which would make the subject, in the opinion of the investigator, unsuitable for the study, or could potentially confound the results of the study
• Concurrent use of other investigational (non-Food and Drug Administration [FDA]-approved) agent or device
• Participation in any other clinical study within 90 days prior to treatment with the study drug
• Female subjects who are pregnant or nursing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.
Experimental: 10 micrograms	Drug: Chrysalin; Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
Experimental: 30 micrograms	Drug: Chrysalin; Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
Experimental: 3 micrograms	Drug: Chrysalin; Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.
Experimental: 1 microgram	Drug: Chrysalin; Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.; Drug: Chrysalin; Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to removal of all rigid immobilization for fracture	Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to clinical healing of the fracture	Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Time to radiographic healing of the fracture	Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of range of motion relative to unbroken wrist	Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Assessment of grip strength relative to unbroken wrist	Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
Results of patient questionnaires	Questionnaires given Weeks 4, 6, 8, 10,12 and 26 after treatment
Incidence of treatment-emergent adverse events	Weeks 1-8, and Weeks 10, 12, 26 and 52 after treatment
Chemistry and hematology laboratory evaluations	Within 24 hours, and at Weeks 2, 4, 8, and 26 after treatment

Collaborators and Investigators

• Sponsor: Capstone Therapeutics
• Investigators: Study Chair: James Ryaby, Ph.D., Capstone Therapeutics

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: August 16, 2005
• First Submitted That Met QC Criteria: August 16, 2005
• First Posted (Estimate): August 18, 2005

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Fracture; Healing; Wrist; Chrysalin; TP508
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Radius Fractures; Hemostatics; Coagulants; Thrombin
• Other Study ID Numbers: OL-ADRFX-03