INTERNATIONAL OPEN-LABEL EXTENSION OF THE PHASE 3 STUDY CL-503012 WITH KIACTA™ IN PATIENTS WITH AA AMYLOIDOSIS

A.T. Development Switzerland SARL,0 个研究点目标入组 9 人开始时间: 2014年9月30日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•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

•Patient has a CrCl ≤15 mL/min.
•Patient has liver enzyme values >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 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•Patient prematurely withdrawn from Study CL-503012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.
•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)

发起方

A.T. Development Switzerland SARL,