JRCT ID: jRCT2031230046
Registered date:21/04/2023
A Phase 3 Study of Sotatercept in Japanese PAH Participants
Basic Information
Recruitment status | Not Recruiting |
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Health condition(s) or Problem(s) studied | Pulmonary Arterial Hypertension (PAH) |
Date of first enrollment | 10/05/2023 |
Target sample size | 35 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | 1. Pulmonary vascular resistance 2. Adverse events 3. Adverse events leading to discontinuation of study intervention |
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Secondary Outcome | 1. 6 minutes walk distance 2. WHO functional class 3. NT-proBNP |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. 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 criteria | 1. 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
Primary Sponsor | Tanaka Yoshiyuki |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT05818137 |
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 |
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 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |