EUCTR2009-011535-12-DE进行中（未招募）不适用
Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patients with Transthyretin Amyloidosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc.
- 入组人数
- 110
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
- •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
排除标准
- •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, indomethicin, 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 alanine transaminase (ALT) and aspartate transaminase, (AST) value >3X ULN that in the medical judgement of the investigator is due to reduced liver function or active disease.
- •6. The patient has received a liver or heart transplant.
- •Sub-study:
- •7. Unwilling to provide written informed consent for this sub-study.
研究者
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