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 (MK-7962-038)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 815
- 试验地点
- 137
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse.
Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH.
This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.
详细描述
LTFU PAH sotatercept study MK-7962-004 (Obsolete Identifier: NCT04796337) has been incorporated into the current MK-7962-038 (NCT07218029) study for administrative reasons. The MK-7962-004 study is no longer enrolling participants and will be formally closed. Only those who participated in MK-7962-004 may be eligible to continue into MK-7962-038.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Has completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
- •Is willing to adhere to the study visit schedule, and understands and will comply with all protocol requirements
- •Must have the ability to understand and provide documented informed consent
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Did not participate in a sotatercept PAH parent study
- •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 that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
- •Is a female who is pregnant or breastfeeding
- •Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study
- •Is currently enrolled in another investigational product study other than a sotatercept study
- •Is incapacitated
研究组 & 干预措施
Sotatercept
Participants enrolling from blinded PAH sotatercept studies will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection and can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study. Participants enrolling from unblinded PAH sotatercept studies will continue sotatercept at their current dose and, if at a dose <0.7 mg/kg, can titrate up to the target dose of 0.7 mg/kg SC injection for the remainder of the study.
干预措施: Sotatercept (Biological)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 90 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Treatment Due to an AE
时间窗: Up to approximately 86 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Number of Participants with Detectable Anti-Drug Antibodies (ADAs)
时间窗: Up to approximately 88 months
ADAs will be detected in serum. The number of participants with detectable ADAs will be reported.
Laboratory parameters (Hematology): Concentration of Platelets and Hemoglobin
时间窗: Up to approximately 88 months
Blood samples will be collected to determine the concentration of platelets and hemoglobin.
Laboratory parameters (Chemistry): Concentration of Creatinine, Total Bilirubin, and Alanine Aminotransferase (ALT)
时间窗: Up to approximately 86 months
Blood samples will be collected to determine the concentration of creatinine, total bilirubin, and ALT.
Change From Baseline in Body Weight
时间窗: Baseline and up to approximately 86 months
Change from baseline in body weight will be reported.
Change From Baseline in Electrocardiogram (ECG)
时间窗: Baseline and up to approximately 86 months
Change from baseline in ECG (12-lead) for the determination of Fridericia's corrected QT interval (QTcF) will be reported.
Change From Baseline in Blood Pressure
时间窗: Baseline and up to approximately 86 months
Change from baseline in systolic and diastolic blood pressure will be reported.
次要结局
- Change From Baseline in 6-Minute Walk Distance (6MWD)(Baseline and up to approximately 48 months)
- Change From Baseline in N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) Levels(Baseline and up to approximately 48 months)
- Change From Baseline in the Percentage of Participants Who Improve or Show Maintenance in Modified New York Heart Association/ World Health Organization Classification of Functional Status (WHO FC)(Baseline and up to approximately 48 months)
- Change From Baseline in Pulmonary Vascular Resistance (PVR)(Baseline and up to approximately 48 months)
- Change From Baseline in Percentage of Participants Who Maintain or Achieve a Low Risk Score Using the Simplified French Risk Score Calculator(Baseline and up to approximately 48 months)