EUCTR2009-011535-12-IT进行中（未招募）1 期
Open-Label Safety and Efficacy Evaluation of Fx-1006A in Patientswith Transthyretin Amyloidosis - ND
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
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.
- •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
- •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. The patient has received a liver or heart transplant.
研究者
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