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The purpose of this study is to allow participants from the LIGHTRAY trial to continue getting Sotatercept (MK-7962) by weight-banded dosing (dose based on weight bands with a different dose assigned to each band) 

Research Objectives

Status

Current

Recruitment

Open

Total participants required

3

Study location

Wesley Research Institute

Study type

Industry Sponsored

Patient group

Adults aged 18 years and above diagnosed with Group 1 Pulmonary Arterial Hypertension who previously participated in the LIGHTRAY trial (MK-7962-024)

About this clinical trial

The LIGHTRAY trial enrolled adults with pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure that affects the arteries that go from the heart to the lungs. It can cause strain on the right side of the heart. This LIGHTRAY EXTENSION trial is being conducted to test the long-term safety of sotatercept given using a weight-banded dosing method. The weight-banded dosing (dose based on weight bands with a different dose assigned to each band) of sotatercept is not currently approved by the Australian TGA outside of clinical trials. However, weight-based dosing (dose based on exact body weight) has been approved in some countries, including Australia, for treating PAH in adults. This trial is for participants who completed the treatment phase of the LIGHTRAY trial (including Visit 11) and did not discontinue sotatercept 

Eligibility

  • Aged 18 years and over
  • Diagnosed with Group 1 Pulmonary Arterial Hypertension
  • Have previously completed the treatment phase of LIGHTRAY trial (including Visit 11)
  • Have not started taking sotatercept that is available for regular (non-trial) use

Lead investigators

  • Dr John Feenstra
  • Dr Jennifer Schafer

Clinical trial coordinator

  • Bronwen Field

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