Clinical trial NCT01112306: ACT-293987 in Pulmonary Arterial Hypertension
Official title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Open-label
PAH
Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-04-28
Enrollment: 709
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)


Eligibility criteria: Inclusion Criteria:

* Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
* Signed informed consent.

Exclusion Criteria:

* Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
* Severe hepatic impairment (Child-Pugh C).
* Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence, or psychiatric disease.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
timeFrame: Up to 3 days after study drug discontinuation (Up to 10.5 years)
measure: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation
timeFrame: Up to 3 days after study drug discontinuation (Up to 10.5 years)
measure: Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention
timeFrame: Up to 10.5 years
Secondary outcomes:
measure: Percentage of Alive Participants
timeFrame: Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Torrance
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Atlanta
country: United States
state: Georgia
city: Augusta
country: United States
state: Georgia
city: Austell
country: United States
state: Georgia
city: Carmel
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Troy
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Chesterfield
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Newark
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Islandia
country: United States
state: New York
city: New York
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Bend
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Doylestown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: York
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Corrientes
country: Argentina
city: Adelaide
country: Australia
city: Bedford Park
country: Australia
city: Chermside
country: Australia
city: Concord
country: Australia
city: Darlinghurst
country: Australia
city: Fitzroy
country: Australia
city: Hobart
country: Australia
city: Murdoch
country: Australia
city: New Lambton
country: Australia
city: Parkville
country: Australia
city: Graz
country: Austria
city: Vienna
country: Austria
city: Minsk
country: Belarus
city: Brussels
country: Belgium
city: Leuven
country: Belgium
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Quebec
country: Canada
city: Santiago De Chile
country: Chile
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Bogota
country: Colombia
city: Praha 2
country: Czechia
city: Arhus
country: Denmark
city: Copenhagen
country: Denmark
city: Bron Cedex
country: France
city: Le Kremlin-Bicetre Cedex
country: France
city: Lille Cedex
country: France
city: Toulouse Cedex 9
country: France
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Giessen
country: Germany
city: Greifswald
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Köln
country: Germany
city: Leipzig
country: Germany
city: Löwenstein
country: Germany
city: Regensburg
country: Germany
city: Alexandroupoli
country: Greece
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Ahmedabad
country: India
city: Chennai
country: India
city: Hyderabad
country: India
city: Dublin
country: Ireland
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petah Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Tel-Hashomer
country: Israel
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kuala Lumpur
country: Malaysia
city: Ciudad de Mexico
country: Mexico
city: Amsterdam
country: Netherlands
city: Maastricht
country: Netherlands
city: Rotterdam
country: Netherlands
city: Lima
country: Peru
city: Gdansk
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Otwock
country: Poland
city: Bucuresti
country: Romania
city: Iasi
country: Romania
city: Barnaul
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Kemerovo
country: Russian Federation
city: Moscow
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Belgrade
country: Serbia
city: Singapore
country: Singapore
city: Bratislava
country: Slovakia
city: Košice
country: Slovakia
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Goteborg
country: Sweden
city: Linköping
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Genève 14
country: Switzerland
city: Lausanne
country: Switzerland
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Khon Kaen
country: Thailand
city: Adana
country: Turkey
city: Istanbul
country: Turkey
city: İzmir
country: Turkey
city: Dnipro
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Actelion
name: Aline Frey
role: STUDY_DIRECTOR
References:
citation: Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.