NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031230046

Registered date:21/04/2023

A Phase 3 Study of Sotatercept in Japanese PAH Participants

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPulmonary Arterial Hypertension (PAH)
Date of first enrollment10/05/2023
Target sample size35
Countries of recruitment
Study typeInterventional
Intervention(s)MK-7962 (Sotatercept) is administered subcutaneously (SC) starting at a dose of 0.3 mg/kg with a target dose of 0.7 mg/kg every 3 weeks (21days)

Outcome(s)

Primary Outcome1. Pulmonary vascular resistance 2. Adverse events 3. Adverse events leading to discontinuation of study intervention
Secondary Outcome1. 6 minutes walk distance 2. WHO functional class 3. NT-proBNP

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria1. Documented diagnostic RHC at any time prior to screening confirming the diagnosis of WHO 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 2. PAH classified as WHO FC I or symptomatic PAH classified as WHO FC II to IV 3. Baseline RHC performed during the Screening Period documenting a minimum PVR of >=400 dyn*sec/cm5 (5 Wood unit) 4. On stable doses of background PAH therapy (i.e., patient-specific dose goal for each therapy already achieved) and diuretics (if applicable) for at least 90 days prior to screening. 5. 6MWD >= 150 and <= 500 m repeated twice at screening (measured at least 4 hours apart, but no longer than 1 week), and both values are within 15% of each other (calculated from the highest value).
Exclude criteria1. Diagnosis of PH WHO Groups 2, 3, 4, or 5. 2. Diagnosis of the following PAH Group 1 subtypes: - human immunodeficiency virus (HIV)-associated PAH - PAH associated with portal hypertension - schistosomiasis-associated PAH - PAH with features of significant venous/capillary (PVOD/PCH) involvement 3. Pregnant or breastfeeding women. 4. History of full or partial pneumonectomy. 5. Pulmonary function test (PFT) values of forced vital capacity (FVC) < 60% predicted at the screening visit or within 6 months prior to the screening visit.

Related Information

Contact

Public contact
Name MSDJRCT inquiry mailbox
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.
Scientific contact
Name Yoshiyuki Tanaka
Address KITANOMARU SQUARE,1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.