Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER

Phase 3

Terminated

Brief Summary: This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

Detailed Description: This extended access study will assess the long-term safety and tolerability of bardoxolone methyl in qualified patients with pulmonary hypertension (PH) who previously participated in controlled clinical studies with bardoxolone methyl.

Qualified patients will receive 10 mg of bardoxolone methyl once daily until the drug is available through commercial channels or until patient withdrawal, whichever is sooner. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

Recruitment & Eligibility

Inclusion Criteria

Treatment-compliant patients who are participating in qualifying ongoing studies and have completed required End-of-Treatment and/or Follow-up visits in a prior clinical study with bardoxolone methyl

Exclusion Criteria

Participation in other investigational clinical studies involving interventional products being tested or used in a way different from the approved form or when used for an unapproved indication;
Patients who have an ongoing SAE from a clinical study that is assessed by the investigator as related to bardoxolone methyl;
Unwilling to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while taking study drug;
Women who are pregnant or breastfeeding;
Patient is, in the opinion of the investigator, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason;
Known hypersensitivity to any component of the study drug

Arm && Interventions

Group	Intervention	Description
Bardoxolone methyl 10 mg	Bardoxolone methyl	Bardoxolone methyl will be administered orally once daily at 10 mg until it becomes commercially available. Dose de-escalation (down to 5 mg) is permitted during the study, if indicated clinically.

Primary Outcome Measures

Name	Time	Method
Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study	From time of first dose until the final visit, up to 172 weeks	Severity was defined using the following definitions: Mild: Symptoms causing no or minimal interference with usual social and functional activities; Moderate: Symptoms causing greater than minimal interference with usual social and functional activities; Severe: Symptoms causing inability to perform usual social and functional activities.

Secondary Outcome Measures

Name	Time	Method

Locations (96): Banner University Medical Center, Phoenix Advanced Lung Disease Institute
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Phoenix, Arizona, United States
Arizona Pulmonary Specialists
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Phoenix, Arizona, United States
Cedars Sinai Medical Center
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Beverly Hills, California, United States
University of California San Diego
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La Jolla, California, United States
VA Healthcare System of Greater Los Angeles
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Los Angeles, California, United States
David Geffen School of Medicine UCLA
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Los Angeles, California, United States
University of California Davis Medical Center - Division of Pulmonary and Critical Care
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Sacramento, California, United States
Harbor - UCLA Medical Center
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Torrance, California, United States
University of Colorado Denver - Division of Pulmonary Sciences
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Aurora, Colorado, United States
Georgetown University Medical Center - Department of Rheumatology
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Washington, District of Columbia, United States
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Banner University Medical Center, Phoenix Advanced Lung Disease Institute
🇺🇸Phoenix, Arizona, United States