ACTRN12624000664549招募中1 期
A Phase 1/2, Multicenter, Dose Escalating, Dose Expanding, Adaptive Study to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of Collagenase CNT201 in Adult Participants with Dupuytren’s Contracture
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Men and women, 18 to 75 years of age, inclusive.
- •2. Women to be included in the study are postmenopausal or agree to use contraception throughout the course of the study. Men should also agree to use a contraceptive method throughout the course of the study.
- •3. Participants with a diagnosis of primary DC, with a fixed flexion deformity of at least 1 finger, other than the thumb, that has a contracture at least 20°, but not greater than 100°, for metacarpophalangeal (MP) not greater than 80° for Proximal interphalangeal (PIP) joints, caused by a palpable cord.
- •4. Participants who have a positive Table Top Test, defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- •5. Participants who are naive to CNT201 treatment.
- •6. Participants who are judged to be in good health, based upon the results of a medical history, physical examination, and safety laboratory profile.
- •7. Participants who are willing to voluntarily sign and date the Informed Consent Form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).
排除标准
- •1. Participants previously exposed to collagenase Clostridium histolyticum for treatment of Dupuytren’s disease (Xiaflex, Xiapex®).
- •2. Participants who exhibit a recurrent DC affecting the selected primary joint, along with a history of other treatments for advanced Dupuytren’s disease, including surgery (fasciectomy or fasciotomy), needle aponeurotomy/fasciotomy.
- •3. Participants who have received injection of verapamil, steroids and/or interferon on the selected primary joint within 90 days before the first dose of study treatment.
- •4. Participants with a chronic muscular, neurological, or neuromuscular disorder that affects the hands, or other medical condition which in the Investigator’s opinion will make the participant unsuitable for enrollment in the study.
- •5. Participants who have a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition (e.g., breast cancer patients with enlarged lymph nodes etc), or history of alcoholism or drug abuse, which in the Investigator’s opinion, would make the participant unsuitable for enrollment in the study.
- •6. Participants with active cardiovascular disease including clinically significant arrhythmias or prolonged QT interval (QTc greater than 450 msec for males and greater than 470 msec for females).
- •7. Participants with secondary DC due to diabetes or liver disease.
- •8. Participants with osteoarthritis or rheumatoid arthritis in the hands, determined by the Investigator based on their review, clinical examination, or X-ray assessment.
- •9. Participants who are human immunodeficiency virus (HIV) positive.
- •10. Participants who have an active infection of tuberculosis (TB).
- •11. Participants who have a known allergic response to collagenase or any other excipient of CNT201.
- •12. Participants who have received a doxycycline or tetracycline derivative within 14 days before the beginning of the study (tetracycline derivatives may inhibit the collagenolytic
- •activity of mammalian collagenase homologs).
- •13. Participants who have received an anticoagulant (except aspirin less than or equal to 150 mg/day) within 7 days before the start of the study.
- •14. Female participants who are nursing or pregnant, or plan to become pregnant during the study treatment stage of the study.
- •15. Participants who have been treated with any investigational drug within 30 days of first dose of study treatment
研究者
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