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)
Brief Title
ACT-293987 in Pulmonary Arterial Hypertension
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pulmonary Arterial Hypertension
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.
* 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.
Inclusion 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.
* 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.
Gender
All
Gender Based
false
Keywords
Open-label
PAH
Pulmonary Arterial Hypertension
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01112306
Org Class
Industry
Org Full Name
Actelion
Org Study Id
AC-065A303
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of ACT-293987 in Patients With Pulmonary Arterial Hypertension
Primary Outcomes
Outcome Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Outcome Measure
Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation
Outcome Time Frame
Up to 3 days after study drug discontinuation (Up to 10.5 years)
Outcome Description
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs.
Outcome Measure
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation
Outcome Time Frame
Up to 3 days after study drug discontinuation (Up to 10.5 years)
Outcome Description
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug.
Outcome Measure
Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention
Outcome Time Frame
Up to 10.5 years
Secondary Ids
Secondary Id
2009-014992-31
Secondary Outcomes
Outcome Description
Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates.
Outcome Time Frame
Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120
Outcome Measure
Percentage of Alive Participants
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
James Tauras
Investigator Email
jtauras@montefiore.org
Investigator Phone