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Clinical Trials List

Protocol NumberMK-7962-031
NCT Number(ClinicalTrials.gov Identfier)NCT06925750
Active

2025-03-01 - 2032-12-31

Phase II

Recruiting3

ICD-10I27.0

Primary pulmonary hypertension

ICD-9416.0

Primary pulmonary hypertension

An Open-label Extension Study to Evaluate Safety and Tolerability of Sotatercept (MK-7962) Administered Using a Weight-banded Approach in Participants With Pulmonary Arterial Hypertension (PAH) on Standard of Care

  • Trial Applicant

    Merck Sharp & Dohme (I.A.) LLC

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/21

Investigators and Locations

Principal Investigator 林坤璋 Division of General Internal Medicine

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shih-Hsien Sung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsin Hsu

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Pulmonary Arterial Hypertension

Objectives

主要目的:評估使用體重分段方法給藥之sotatercept的長期安全性和耐受性。 探索性目的:使用體重分段方法給藥,評估sotatercept對N端前B型利鈉利尿胜肽(NT-proBNP)濃度的長期影響。

Test Drug

凍晶乾燥注射劑

Active Ingredient

Sotatercept

Dosage Form

245

Dosage

45 mg/vial

Endpoints

不良事件(AE)以及因AE造成的試驗治療停止

Inclution Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has completed the treatment period of study MK-7962-024 (LIGHTRAY) (including Visit 11) on study intervention, did not discontinue study intervention, and is able to safely enroll into MK-7962-031 (LIGHTRAY EXTENSION)
Has not started treatment with commercially available sotatercept

Exclusion Criteria

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

- Has current exposure or is planning to begin treatment with an activin signaling inhibitor (other than sotatercept)

The Estimated Number of Participants

  • Taiwan

    9 participants

  • Global

    130 participants