Open-label Extension Study of GB002 in Adult Patients with PAH
Research type
Research Study
Full title
An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Oral Inhalation of GB002 for the Treatment of WHO Group 1 Pulmonary Arterial Hypertension (PAH)
IRAS ID
297464
Contact name
Luke Howard
Contact email
Sponsor organisation
GB002, Inc.
Eudract number
2020-005169-15
Duration of Study in the UK
2 years, 10 months, 0 days
Research summary
The purpose of this research is to learn about the safety and long-term effects of a new investigational drug called GB002 as a possible treatment for Pulmonary Arterial Hypertension PAH. PAH is a condition that causes high blood pressure in the arteries of the lungs. PAH is caused by thickening and narrowing of the small arteries, which leads to increased pressure. GB002 is an investigational drug that is designed to slow or possibly reverse the narrowing of arteries and small blood vessels of the lungs in patients with PAH.
Patients will be required to visit the clinic up to 12 times and complete 1 phone visit over the 76-week study period.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0344
Date of REC Opinion
11 Jun 2021
REC opinion
Further Information Favourable Opinion