EUCTR2013-004150-16-LT进行中（未招募）1 期
International Open-Label Extension of the Phase 3 Study CL-503012 with KIACTA™ in Patients with AA Amyloidosis
A.T. Development Switzerland SAR0 个研究点目标入组 70 人开始时间: 2014年4月7日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patient has completed Study CL-503012, and has undergone all study assessments that
- •could affect the primary endpoint of Study CL-503012
- •- Patient is at least 18 years of age
- •- Patient has a negative pregnancy test, if a female patient of childbearing potential
- •- Patient is willing to use effective birth control method. Women of childbearing potential
- •should continue to use effective birth control method as follows:
- •- Oral contraception with an additional barrier method (since the investigational
- •product may impair effectiveness of oral contraception)
- •- Double-barrier method (diaphragm with spermicidal gel or condom with
- •contraceptive foam)
- •- Transdermal or long-acting injected contraceptive (e.g., depot
- •medroxyprogesterone acetate [Depo-Provera®])
- •- Intrauterine device or implantable contraceptive
- •- Partner who is surgically sterile (vasectomy)
- •- Total abstinence
- •Nonsurgically sterile men should use double-barrier method as described above during
- •intercourse for the duration of the treatment with Kiacta.
- •- Patient has provided written informed consent to participate in this OLE study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •- Patient has a CrCl =15 mL/min (as estimated by the Cockcroft-Gault formula prior to
- •entering into the program
- •- Patient has liver enzyme values (aspartate aminotransferase, alanine aminotransferase, or
- •alkaline phosphatase) >5 times the upper limit of normal and/or total bilirubin >50%
- •higher than the upper limit of normal
- •- Patient progressed to ESRD during Study CL-503012. In Study CL-503012 ESRD was
- •defined as one of the following:
- •i. Presence of Stage 5 chronic kidney disease, i.e., established kidney failure
- •with an eGFR <15 mL/min, obtained from 2 distinct SCr measurements
- •separated by 2 to 4 weeks (Visit X and Visit X plus 2 to 4 weeks) or
- •ii. Initiation of permanent renal replacement therapy, defined as a need for
- •chronic dialysis (duration of 3 months or more) or transplantation
- •- Patient was noncompliant while in Study CL-503012
- •- Patient prematurely withdrawn from Study CL-503012
- •- Patient has a clinically significant disease that could compromise patient’s safety
- •- Patient suffers from active alcohol and/or drug abuse
- •- Patient is pregnant or lactating, or patient is a woman of childbearing potential and is
- •unwilling to use a clinically approved form of contraception during the program
- •(continuous use of oral or long-acting injected contraceptive and/or use of an intra-uterine
- •device or implantable contraceptive, and/or use of a barrier method of birth control)
- •- Patient was on other investigational drug(s) given within 30 days prior to entry into this
- •program or during this program (with the exception of study drug taken in previous
- •CL-50312 program
研究者
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