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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Time to removal of all rigid immobilization for fracture
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
10 micrograms
干预措施: Chrysalin (Drug)
30 micrograms
干预措施: Chrysalin (Drug)
Placebo
干预措施: Placebo (Drug)
3 micrograms
干预措施: Chrysalin (Drug)
1 microgram
干预措施: Chrysalin (Drug)
结局指标
主要结局
Time to removal of all rigid immobilization for fracture
时间窗: Assessed Weeks 1-8, and Weeks 10, 12 and 26 after treatment
次要结局
- 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)
- Time to clinical healing of the fracture(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)