2023-509138-21-00招募中3 期
An Open-Label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 407
- 试验地点
- 64
- 主要终点
- • Adverse events (AEs) • Anti-drug antibodies (ADA) • Clinical laboratory assessments (hematology, serum chemistry/follicle-stimulating hormone (FSH), and urinalysis) • Vital signs • 12-lead electrocardiogram (ECG)
研究概览
简要总结
The primary objective of this open-label, LTFU study is to evaluate the long-term safety and tolerability of sotatercept when added to background PAH therapy in adult participants with PAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Visit
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must have completed their current respective PAH sotatercept clinical study, must have completed the parent study requirements, and must not have discontinued early.
- •Participants must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements.
- •Participants must have the ability to understand and provide documented consent
- •Females of childbearing potential must: a. Have a negative pregnancy tests as verified by the investigator prior to starting study drug administration; she must agree to ongoing pregnancy testing during the course of the study and until 8 weeks after the last dose of the study drug. b. If sexually active, have used, and agree to continue to use highly effective contraception in combination with a barrier method without interruption, for at least 28 days prior to starting the investigational product, during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study drug. c. Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study drug.
- •Male participants must: a. Agree to use a condom, defined as a male latex condom or non-latex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy b. Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study drug.
- •Participants must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the A011-12 study
排除标准
- •Did not participate in a sotatercept PAH parent trial.
- •Missed more than the equivalent of 4 consecutive doses between the end of parent study and the start of this study.
- •Presence of an ongoing Serious Adverse Event (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept.
- •Pregnant or breastfeeding females.
结局指标
主要结局
• Adverse events (AEs) • Anti-drug antibodies (ADA) • Clinical laboratory assessments (hematology, serum chemistry/follicle-stimulating hormone (FSH), and urinalysis) • Vital signs • 12-lead electrocardiogram (ECG)
• Adverse events (AEs) • Anti-drug antibodies (ADA) • Clinical laboratory assessments (hematology, serum chemistry/follicle-stimulating hormone (FSH), and urinalysis) • Vital signs • 12-lead electrocardiogram (ECG)
次要结局
- • 6-minute walk distance (6MWD) • N-terminal pro-hormone B-type natriuretic peptide • World Health Organization (WHO) functional class • Pulmonary vascular resistance • Overall survival • Simplified French Risk score
研究者
Howard Julien
Scientific
Acceleron Pharma Inc.
研究点 (64)
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