Study assessing long-term safety of bardoxolone methyl in PH patients
Research type
Research Study
Full title
AN EXTENDED ACCESS PROGRAM TO ASSESS LONG-TERM SAFETY OF BARDOXOLONE METHYL IN PATIENTS WITH PULMONARY HYPERTENSION
IRAS ID
223840
Contact name
John Gerard Coghlan
Contact email
Sponsor organisation
Reata Pharmaceuticals, Inc.
Eudract number
2016-004365-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 3 months, 14 days
Research summary
Pulmonary hypertension (PH) is high blood pressure within the pulmonary arteries (blood vessels that supply the lungs). PH causes the pulmonary artery walls to be thick and stiff; reducing blood flow causing the heart to work harder to pump blood. If the heart has to continually work harder, it may gradually become weaker making it less efficient at pumping blood and can lead to heart failure. \n\nThis extended access study, sponsored by Reata Pharmaceuticals, Inc., will assess the long-term safety and tolerability of bardoxolone methyl in PH patients who previously participated in controlled clinical studies with bardoxolone methyl (‘CATALYST’ and ‘LARIAT’). \n\nBardoxolone methyl directly targets the bioenergetic and inflammatory components of PH. Bardoxolone methyl has the potential to improve metabolism and mitochondrial function while also inhibiting inflammatory and proliferative signaling. It is thought that by addressing a novel pathway in PH, bardoxolone methyl may provide additional benefits beyond current PAH therapies. \n\nThe available safety data from a previous study suggests that bardoxolone methyl is well-tolerated in PAH patients when administered on top of current standard-of-care therapies. Approximately 1950 individuals have been exposed to bardoxolone methyl, including healthy volunteers, cancer patients, kidney disease patients, and PH patients.\n\nParticipants will receive 10 mg (or a lower dose, if needed) of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. \n\nAll treatment-compliant patients participating in qualifying ongoing studies who have completed the required visits in a prior clinical study with BARD will be allowed to participate in this study. Approximately 150 centres worldwide will participate in this study.\n\nAll participants will be assessed in person during treatment at Day 1, Week 4, Week 24, and every 24 weeks thereafter. Participants will also be assessed by telephone contact on Day 10.
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0724
Date of REC Opinion
14 Jun 2017
REC opinion
Further Information Favourable Opinion