EUCTR2013-004561-13-ES进行中（未招募）不适用
An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of ISIS 420915 in Patients with Familial Amyloid Polyneuropathy (FAP) - ISIS 420915-CS3
Isis Pharmaceuticals, Inc0 个研究点目标入组 195 人开始时间: 2015年10月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 195
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. Completion of ISIS 420915-CS2 with the following as judged by the Investigator and Sponsor:
- •a. Satisfactory completion of dosing and end of treatment (EOT) efficacy assessments
- •b. No significant tolerability issues
- •c. Satisfactory compliance to the ISIS 420915-CS2 protocol requirements
- •2. Willingness to take vitamin A supplements
- •3. Satisfy one of the following:
- •a. Females: Non-pregnant and non-lactating; surgically sterile, postmenopausal, abstinent, or if engaged in sexual relations of childbearing potential, patient is using an acceptable contraceptive method (refer to Section 6.3.1) from the time of signing the informed consent form until at least 3 months after the last dose of ISIS 420915.
- •b. Males: Surgically sterile, abstinent, or if engaged in sexual relations with a female of childbearing potential, patient is utilizing an acceptable contraceptive method (refer to Section 6.3.1) during and for 3 months after the last dose of ISIS 420915.
- •4. Must have given written informed consent (signed and dated) and any authorization required by local law and be able to comply with all 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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Have any new condition or worsening of existing condition that in the opinion of the Investigator or Sponsor would make the patient unsuitable for enrollment, or could interfere with the patient participating in or completing the study.
研究者
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