A Phase 2, Multicenter, Open-label Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) With Heart Failure With Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 102
- 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 new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF).
Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time.
The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.
详细描述
This is an extension study for studies MK-7962-007 (NCT04945460) and MK-7962-041 (NCT number pending).
Following protocol amendment 3, all participants in the Sotatercept 0.7 mg/kg arm will switch to the Sotatercept 0.3 mg/kg arm, and new participants will only enroll in the Sotatercept 0.3 mg/kg arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Investigator, Outcomes Assessor)
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:
- •- Completed sotatercept parent study (MK-7962-007[CADENCE] [Visit 9 and EOT visit] or MK-7962-041 [P041] [EOT Visit]) without discontinuing study intervention and is able to safely enroll into MK-7962-023 (HARMONIZE)
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
- •Has had a study intervention interruption and has an ongoing SAE that occurred during parent study and is suspected to be related to study intervention
- •Is pregnant or breastfeeding
- •Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
- •Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
- •Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
- •Anticipated or undergone heart transplant or ventricular assist device implantation
- •Has had prior exposure to luspatercept
研究组 & 干预措施
Sotatercept 0.3 mg/kg
Participants receive sotatercept 0.3 mg/kg subcutaneous (SC) injection every 3 weeks (Q3W) for up to approximately 10 years or until discontinuation.
干预措施: Sotatercept (Biological)
Sotatercept 0.7 mg/kg
Participants receive sotatercept 0.7 mg/kg SC injection Q3W for up to approximately 10 years or until discontinuation.
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 10 years
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 10 years
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.
次要结局
- Change From Parent Study Baseline in Pulmonary Vascular Resistance (PVR) at 6 Months Following Enrollment in the Extension(Baseline and Month 6)
- Change From Baseline in the 6-Minute Walk Distance (6MWD) at 6 Months Following Enrollment in the Extension(Baseline and Month 6)
- Change From Baseline in the 6MWD at 12 Months Following Enrollment in the Extension(Baseline and Month 12)
- Change From Baseline in the 6MWD at 18 Months Following Enrollment in the Extension(Baseline and Month 18)
- Change From Baseline in the 6MWD at End of Treatment(Baseline and up to approximately 43.5 months)
- Change From Baseline in New York Heart Association Functional Class (NYHA FC) at 6 Months Following Enrollment in the Extension(Baseline and Month 6)
- Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension(Baseline and Month 12)
- Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension(Baseline and Month 18)
- Change From Baseline in NYHA FC at End of Treatment(Baseline and up to approximately 10 years)
- Change From Baseline in N-terminal Pro-hormone Brain Natriuretic Peptide (NT-proBNP) at 6 Months Following Enrollment in the Extension(Baseline and Month 6)
- Change From Baseline in NT-proBNP at 12 Months Following Enrollment in the Extension(Baseline and Month 12)
- Change From Baseline in NT-proBNP at 18 Months Following Enrollment in the Extension(Baseline and Month 18)
- Change From Baseline in NT-proBNP at End of Treatment(Baseline and up to approximately 10 years)
- Change From Parent Study Week 24 in PVR at 6 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 6)
- Change From Baseline in 6MWD at 6 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 6)
- Change From Baseline in 6MWD at 12 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 12)
- Change From Baseline in 6MWD at 18 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 18)
- Change From Baseline in 6MWD at End of Treatment for Placebo Participants(Baseline and up to approximately 43.5 months)
- Change From Baseline in NYHA FC at 6 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 6)
- Change From Baseline in NYHA FC at 12 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 12)
- Change From Baseline in NYHA FC at 18 Months Following Enrollment in the Extension for Placebo Participants(Baseline and Month 18)
- Change From Baseline in NYHA FC at End of Treatment for Placebo Participants(Baseline and up to approximately 10 years)