Weight-banded Versus Weight-based Dose PK and Safety Evaluation for Sotatercept in Participants with PAH

JRCT ID: jRCT2061240077

Registered date:07/11/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pulmonary Arterial Hypertension
• Date of first enrollment: 23/12/2024
• Target sample size: 160
• Countries of recruitment: US,Japan,Canada,Japan,Australia,Japan,Singapore,Japan,Korea,Japan,Taiwan,Japan,Thailand,Japan,China,Japan,Argentina,Japan,Colombia,Japan,Czech Republic,Japan,France,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Turkey,Japan,UK,Japan
• Study type: Interventional
• Intervention(s): MK-7962 (sotatercept) is administered subcutaneously using either a weight-based or weight-banded approach

Outcome(s)

Primary Outcome

-Steady-state average serum concentration
-Adverse Events (AEs), Discontinuation of study intervention due to Aes

• Secondary Outcome: -Initial dose average serum concentration

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- Has documented diagnostic Right Heart Catheterization, with the diagnosis of World Health Organization (WHO) Pulmonary Atrial Hypertension (PAH) Group 1 in any of the following subtypes: Idiopathic PAH, Heritable PAH, Drug/toxin-induced PAH, PAH associated with connective tissue disease, PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair
- Has symptomatic PAH classified as WHO Functional Class II or III

Exclude criteria

- Has a weight of <35 kg
- Has a diagnosis of PH WHO Groups 2, 3, 4, or 5
- Has a diagnosis of the following PAH Group 1 subtypes: HIV-associated PAH, PAH associated with portal hypertension, Exclusion in PAH Group 1 should also include schistosomiasis-associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
- Has uncontrolled systemic hypertension
- Has a history of pneumonectomy
- Has a history of known pericardial constriction
- Has a history of restrictive cardiomyopathy
- Has history of atrial septostomy (within 180 days prior to study start)
- Has personal or family history of long QT syndrome
- Has history of coronary artery disease (myocardial infarction, percutaneous coronary intervention, coronary artery bypass, graft surgery, or cardiac anginal chest pain) (within 6 months prior to study start)
- Has a cerebrovascular accident (within 3 months prior to study start)
- Has significant (>2+ regurgitation) mitral regurgitation or aortic regurgitation valvular disease
- Has untreated more than mild obstructive sleep apnea
- Has known malignancy that is progressing or has required active treatment within the past 5 years
- Has recently started (within 12 months prior to study start) or has plans to start weight loss medication or enter a weight loss program during the study period
- Has a previous (within 3 years) or planned (during the study) obesity treatment with surgery or a weight-loss device

Related Information

• Primary Sponsor: Masayuki Kobayashi
• Secondary ID(s): NCT06664801