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-7962-004)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 815
- 试验地点
- 189
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept (MK-7962, formerly called ACE-011) in participants with Pulmonary Arterial Hypertension (PAH). This open-label, long-term follow-up (LTFU) study is supported by data from the PULSAR study (Phase 2, NCT03496207) in which treatment with sotatercept resulted in hemodynamic and functional improvements in the study participants, including those receiving maximal PAH therapy with double/triple drug combinations and intravenous prostacyclin.
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 who have completed prior sotatercept studies. The secondary objective is to evaluate continued efficacy in adult participants with PAH who have completed prior sotatercept studies.
详细描述
Participants eligible to enroll in this study will have participated in and completed the relevant study requirements of the parent PAH sotatercept clinical studies.
Participants enrolled in this study may be eligible to participate in MK-7962-038 (NCT number pending), an open-label LTFU study to evaluate the effects of sotatercept when added to background PAH therapy.
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
- •Have completed their current respective PAH sotatercept clinical study and its requirements, and must not have discontinued early
- •Must be willing to adhere to the study visit schedule and understand and comply with all protocol requirements
- •Must have the ability to understand and provide documented informed consent
- •Females of childbearing potential must:
- •Have a negative pregnancy test 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
- •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
- •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:
- •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
- •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
- •Must agree not to participate in any other trials of investigational drugs/devices while they are enrolled in the MK-7962-004 study, except for the MK-7962-038 study
排除标准
- •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 (SAE) that occurred during a PAH sotatercept clinical study that is assessed to be possibly or probably related to sotatercept
- •Pregnant or breastfeeding females
研究组 & 干预措施
Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg subcutaneous (SC) injection for Visit 1. Dose will escalate to 0.7 mg/kg SC injection at Visit 2 through the remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and, if at a dose <0.7 mg/kg SC injection, can titrate up to 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 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. 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 50 months
AE is any untoward medical occurrence in a clinical investigation participant administered a study drug, which does not necessarily have a causal relationship with this treatment. 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 50 months
ADAs will be detected in serum. The number of participants with detectable ADAs will be presented.
Laboratory parameters (Hematology): Concentration of Red Blood Cell Count, White Blood Cell Count, Platelet Count, Hemoglobin and Hematocrit
时间窗: Up to approximately 50 months
Blood samples will be collected to determine concentration of red blood cell count, white blood cell count, platelet count, hemoglobin and hematocrit at designated timepoints up to approximately 50 months.
Laboratory parameters (Chemistry): Concentration of Blood Urea, Creatinine, Total Bilirubin, Direct Bilirubin, AST, ALT, ALP, Sodium, Potassium, Chloride, Calcium, Phosphorous, Glucose, Magnesium, Carbon Dioxide, and Albumin
时间窗: Up to approximately 50 months
Blood samples will be collected to determine concentration of blood urea, creatinine, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), sodium, potassium, chloride, calcium, phosphorous, glucose, magnesium, carbon dioxide, and albumin at designated time points for up to approximately 50 months.
Change From Baseline in Body Weight
时间窗: Baseline and up to approximately 48 months
Change from baseline in body weight will be reported at designated time points up to approximately 48 months.
Change From Baseline in Blood Pressure
时间窗: Baseline and up to approximately 48 months
Change from baseline in systolic and diastolic blood pressure will be reported at designated time points up to approximately 48 months.
Change From Baseline in Electrocardiogram (ECG)
时间窗: Baseline and up to approximately 48 months
Change from baseline in ECG (12-lead) for the determination of QTcF interval will be reported at designated time points up to approximately 48 months.
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 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)