Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Number of participants administered omecamtiv mecarbil during the treatment period
研究概览
简要总结
The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.
详细描述
This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Participant has provided GALACTIC-HF PTA informed consent prior to initiation of any study specific activities/procedures.
- Participant has completed GALACTIC-HF.
排除标准
- Investigational product was permanently discontinued during GALACTIC-HF due to protocol-specified reason.
- Female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment.
- Female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with OM and for an additional 5 days after the last dose of treatment.
- Female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test.
- Participant has known sensitivity to any of the products or components to be administered during dosing.
- History or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
Omecamtiv mecarbil
All subjects will be assigned to OM
干预措施: Omecamtiv mecarbil (Drug)
结局指标
主要结局
Number of participants administered omecamtiv mecarbil during the treatment period
时间窗: Up to 252 weeks
Primary analysis is based on the exploratory outcome measure.
次要结局
未报告次要终点
研究者
标识符
- NCT 编号
- NCT04464525
- 其他研究编号
- 20190370
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (下个月)
- 研究完成日期
- (下个月)
- 最近核实
- 最近更新
- (5年前)
监管与共享
- FDA 监管药物
- 是
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.