Clinical trial NCT03068130: Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension RANGER
Official title: An Extended Access Program to Assess Long-term Safety of Bardoxolone Methyl in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Pulmonary Hypertension
PH
PAH
Bardoxolone methyl
6-minute walk distance
CDDO-ME
RTA 402
LARIAT
CATALYST
RANGER
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2017-03-01
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long Term Safety as Measured by Incidence and Severity of Adverse Events During the Duration of the Study
timeFrame: From time of first dose until the final visit, up to 172 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center, Phoenix Advanced Lung Disease Institute
state: Arizona
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Beverly Hills
country: United States
facility: Cedars Sinai Medical Center
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: VA Healthcare System of Greater Los Angeles
state: California
city: Los Angeles
country: United States
facility: David Geffen School of Medicine UCLA
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center - Division of Pulmonary and Critical Care
state: California
city: Torrance
country: United States
facility: Harbor - UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver - Division of Pulmonary Sciences
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center - Department of Rheumatology
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic of Florida
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Austell
country: United States
facility: Piedmont-Georgia Lung
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center - Division of Pulmonary and Critical Care Medicine
state: Maine
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester - University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati - Department of Internal Medicine Pulmonary, Critical Care & Sleep Medicine
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute
state: Texas
city: Houston
country: United States
facility: The University of Texas - Health Science Center & Medical School at Houston
state: Texas
city: Houston
country: United States
facility: University of Texas Houston - Division of Rheumatology and Clinical Immunogenetics
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Aurora Health Care
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Centro Médico Dra de Salvo
state: Ciudad Autónoma De BuenosAires
city: Buenos Aires
country: Argentina
facility: Instituto de Investigaciones Clínicas Mar Del Plata
state: Mar Del Plata
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Médico de Córdoba
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes Juana Francisca Cabral
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario
city: Santa Fe
country: Argentina
facility: Hospital Provincial Dr Jose Maria Cullen
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Brussels
country: Belgium
facility: Hospital Erasme
city: Porto Alegre
country: Brazil
facility: Irmandade Da Santa Casa de Misericordia de Porto Alegre
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: Hospital Dia do Pulmão
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Instituto do Coração - HCFMUSP
city: Calgary
country: Canada
facility: Peter Lougheed Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Sainte Foy
country: Canada
facility: Centre Hospitalier de l'Université Laval
state: Quebec
city: Prague
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Prague
country: Czechia
facility: Institut klinicke a experimentalni mediciny
city: Dresden
country: Germany
facility: Universitatsklinkum Carl Gustav Carus an der Tu
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg Eppendorf
city: Heidelberg
country: Germany
facility: Thorax Klinik
city: Jerusalem
country: Israel
facility: Hadassah University Hospital Ein Kerem
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
state: Bunkyo-ku
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Tokyo
country: Japan
facility: Kyorin University Hospital
state: Mitaka-shi
city: Okayama-shi
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Chiba
country: Japan
facility: Chiba University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sendai-shi
country: Japan
facility: Kurume University Medical Center
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: Nuevo León
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez
state: Monterrey
city: Monterrey
country: Mexico
facility: Unidad de Investigación Clínica En Medicina SC
state: Nuevo Leon
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
state: Noord-Holland
city: Quezon City
country: Philippines
facility: Philippine Heart Center
state: Metro Manila
city: Makati
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Philippine General Hospital (PGH)
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
References: