EUCTR2013-004090-28-IT进行中（未招募）不适用
TRANSTHYRETIN-ASSOCIATED AMYLOIDOSES OUTCOMES SURVEY(THAOS) – OPTIONAL BLOOD SAMPLE COLLECTION SUBSTUDY
Fold RX Pharmaceuticals, a Pfizer Company0 个研究点目标入组 45 人开始时间: 2014年3月31日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 45
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
- •Subject has symptomatic ATTR disease with documented Val30Met,
- •Phe64Leu, Thr60Ala, Ser50Arg, Ile107Val, Val20Ile, Ile68Leu, or
- •mutation in the TTR gene.
- •2. Must be able to be a participant in the THAOS registry and are either
- •XML File Identifier: HMmrmo7rsZGmYHxB4NUacap1qIE=
- •Page 7/14 21/01/2014
- •enrolled or will be enrolled in THAOS prior to entry into this substudy.
- •3. Subject provides written informed consent to participate in this
- •substudy. Subject
- •must have already provided written informed consent to participate in
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1. Subject has a diagnosis of primary or secondary amyloidosis.
- •2. Subject has a documented mutation in the TTR gene other than
- •Val30Met, Glu89Gln,
- •Phe64Leu, Thr60Ala, Ser50Arg, Ile107Val, Val20Ile, Ile68Leu, or
- •3. Subject has received a liver transplant.
- •4. Subject does not have symptomatic ATTR disease.
- •5. Subject has received treatment with tafamidis prior to entry into this
- •6. Subjects using non-steroidal anti-inflammatory drugs (NSAIDs) that
- •permitted in the protocol within 2 weeks prior to blood collection.
- •? The following NSAIDs are permitted: acetylsalicylic acid, etodolac,
- •indomethicin, ketoprofen, nabumetone, naproxen, nimesulide,
- •piroxicam, and
- •7. Subject received an investigational drug in another clinical
- •investigational study
- •within 30 days (or as determine by the local requirements, whichever
- •is longer) or
- •5 half-lives prior to substudy enrollment and blood collection.
- •8. Participation in other studies (other than the THAOS survey) that
- •include medication
- •treatment within 6 months prior to substudy enrollment and blood
- •collection.
- •9. Subjects who are investigational site staff members directly involved
- •in the conduct
- •of the trial and their family members, site staff members otherwise
- •supervised by the
- •Investigator, or subjects who are Pfizer employees directly involved in
- •the conduct
研究者
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