Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis

Pfizer Inc.0 个研究点目标入组 110 人开始时间: 2009年7月15日最近更新: 2016年4月11日

适应症

试验速览

暂无简介。

•1. Patient has successfully completed either Protocol Fx-006 or Fx1A-201.
•2. If female, patient is post-menopausal, surgically sterilized, or willing to use two acceptable methods of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) throughout the study and for 3 months from the end of the study. (A condom alone is not considered an acceptable method of birth control.).
•3. Patient is, in the opinion of the investigator, willing and able to comply with the investigational product regimen and all other study requirements.
•Sub-study:
•4.Decrease in creatinine clearance to < 30 mL/minute, or the need for chronic dialysis.
•5.Willing to provide written informed consent for this sub-study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 110
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Patient has not successfully completed either Protocol Fx-006 or Fx1A-201.
•2. Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs), defined as greater than 3 to 4 times/month. The following NSAIDs are allowed: acetylsalicylic acid, etodolac, ibuprofen, indomethacin, ketoprofen, nabumetone, naproxen, nimesulide, piroxicam, and sulindac.
•3. If female, patient is pregnant or breast feeding.
•4. Clinically significant medical condition that, in the opinion of the investigator, would place the patient at an increased risk to participate in the study.
•5/ An ALT and AST value>3X ULN that in the medical judgment of the investigator is due to reduced liver function or active liver disease.
•6. The patient has received a liver or heart transplant.
•Unwilling to provide written informed consent for this sub study.

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