A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004) (SOTERIA)
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|ClinicalTrials.gov Identifier: NCT04796337|
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : November 28, 2022
This study is being conducted to assess the long-term safety, tolerability, and efficacy of sotatercept 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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension PAH||Biological: Sotatercept||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||May 12, 2021|
|Estimated Primary Completion Date :||September 30, 2027|
|Estimated Study Completion Date :||November 30, 2027|
Experimental: Sotatercept Treatment
Participants rolling over from a blinded parent study will begin sotatercept at a dose of 0.3 mg/kg SC for Visit 1. Dose will escalate to 0.7 mg/kg SC at Visit 2 through remainder of the study. Participants rolling over from an unblinded parent study will continue sotatercept at their current dose and if at dose < 0.7 mg/kg SC can titrate up to 0.7 mg/kg SC for the remainder of the study.
Sotatercept subcutaneous injection at a dose of 0.3 to 0.7 mg/kg.
- Number of participants with adverse events (AEs) [ Time Frame: Up to 200 weeks ]The number of participants with AEs will be presented. An 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.
- Number of participants with detectable anti-drug antibodies (ADAs) [ Time Frame: Up to 200 weeks ]The number of participants with detectable ADAs will be presented.
- Incidence of abnormal hematology laboratory test results [ Time Frame: From date of first visit up to 200 weeks ]Based upon complete blood cell count, including red blood cell count, absolute white blood cell count, hemoglobin, hematocrit and platelet count
- Incidence of abnormal clinical chemistry laboratory test results [ Time Frame: From date of first visit up to 200 weeks ]Based upon blood urea nitrogen, creatinine, total bilirubin, direct bilirubin, AST/ALT, alkaline phosphatase, electrolytes, glucose and carbon dioxide.
- Assessment of vital signs - body weight [ Time Frame: From date of first visit up to 200 weeks ]
- Assessment of vital signs - blood pressure (systolic/diastolic) [ Time Frame: From date of first visit up to 200 weeks ]
- Assessment of vital signs - electrocardiogram (12-lead) for the determination of QTcF interval [ Time Frame: From date of first visit up to 200 weeks ]
- Incidence of abnormal urinalysis results [ Time Frame: From date of first visit up to 200 weeks ]Based upon dipstick assessment of urine specific gravity, pH, glucose, bilirubin, ketone and protein
- Change in 6-minute walk distance (6MWD) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
- Change in serum N-Terminal Pro-Hormone B-type Natriuretic Peptide (NT-proBNP) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
- Change in WHO Functional Class (FC) [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
- Pulmonary vascular resistance (PVR) as determined by right heart catheterization [ Time Frame: Measured at the year 4 Visit ]
- Overall Survival (OS) [ Time Frame: From initiation of treatment Visit 1 to the end of study follow-up Visit 8 weeks after year 4 ]
- Proportion of participants who maintain or achieve a low risk score using the simplified French Risk score calculator. [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
Composed of the following parameters:
- WHO FC (I-II)
- 6MWD > 440 meters
- NT-proBNP < 300 ng/L
- Change in Borg CR10 Scale (Borg Dyspnea Scale), a measure of exercise tolerance; numerical scale from 0 to 10, with higher number representative of greater exertion. [ Time Frame: From initiation of treatment Visit 1 to year 4 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796337
|Contact: Toll Free Number||1-888-577-8839||Trialsites@merck.com|
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|