Lightray OLE
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
Recruitment
Total participants required
Study location
Study type
Patient group
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