PER-058-08已完成未知
ong term single-arm open label extension study of the SERAPHIN study to assess the safety and tolerability of ACT-064992 in patients with symptomatic pulmonary arterial hypertension Acronym SERAPHIN (OL)- Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 至 90（—）
- 性别
- All
入选标准
- •Signed informed consent before initiating any procedure specific to the study.
- •Patients with symptomatic pulmonary arterial hypertension and who have concluded the study activated by event, AC-055-302 / SERAPHIN, or patients who have suffered a morbidity and in which a written approval to enter the study has been obtained from the sponsor
- •Pregnancy - Not allowed during the study: The participation of women with pregnancy potential is allowed with a negative test of pregnancy in serum before treatment, using correctly and consistently (from the selection and up to 28 days after the suspension) of treatment) a reliable contraceptive method with a Pearl index <1% (oral hormonal contraceptive, implant, hormonal vaginal ring or intrauterine device, who abstain sexually or have a sexual partner with vasectomy.
排除标准
- •Any major violation of the AC-055-302 / SERAPHIN protocol.
- •Pregnancy or breastfeeding.
- •AST and / or ALT> 3 times the upper limit of the normal range.
- •Any known factor or disease that could interfere with adherence to treatment, conduct of study or interpretation of results, such as dependence on a drug or alcohol, or psychiatric illness.
- •Known hypersensitivity to ACT-064992 or any of its excipients.
研究者
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