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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

274 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radius Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Patients were treated with a single percutaneous injection of Chrysalin 3 micrograms at the fracture site at the time of surgery.

Intervention Type DRUG

Chrysalin

Patients were treated with a single percutaneous administration of Chrysalin 1 microgram at the fracture site at the time of surgery.

Intervention Type DRUG

Chrysalin

Patients were treated with a single percutaneous administration of Chrysalin 10 micrograms at the fracture site at the time of surgery.

Intervention Type DRUG

Chrysalin

Patients were treated with a single percutaneous administration of Chrysalin 30 micrograms at the fracture site at the time of surgery.

Intervention Type DRUG

Placebo

Patients were treated with a single percutaneous administration of placebo at the fracture site at the time of surgery.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No