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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00667823
Registration number
NCT00667823
Ethics application status
Date submitted
24/04/2008
Date registered
28/04/2008
Date last updated
10/02/2022
Titles & IDs
Public title
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
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Scientific title
Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
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Secondary ID [1]
0
0
AC-055-303
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Universal Trial Number (UTN)
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Trial acronym
SERAPHIN OL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension
0
0
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Condition category
Condition code
Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Cardiovascular
0
0
0
0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Macitentan
Experimental: ACT-064992 - ACT-064992
Treatment: Drugs: Macitentan
Tablet, oral administration, 10 mg dose once daily
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation
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Assessment method [1]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.
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Timepoint [1]
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Up to 28 days after study treatment discontinuation (Up to 12 years)
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Primary outcome [2]
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Number of Participants With Death up to 28 Days After Study Treatment Discontinuation
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Assessment method [2]
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Number of participants with deaths up to 28 days after study treatment discontinuation were reported.
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Timepoint [2]
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Up to 28 days after study treatment discontinuation (Up to 12 years)
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Primary outcome [3]
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Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation
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Assessment method [3]
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An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.
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Timepoint [3]
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Up to 28 days after study treatment discontinuation (Up to 12 years)
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Primary outcome [4]
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Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment
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Assessment method [4]
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Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Timepoint [4]
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Up to 28 days after study treatment discontinuation (Up to12 years)
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Primary outcome [5]
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Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation
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Assessment method [5]
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Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (\>) 3\*upper limit of normal (ULN) or aspartate aminotransferase (AST) \>3\* ULN, ALT \>5\* ULN or AST \>5\*ULN, ALT \>8\*ULN or AST \>8\*ULN, total bilirubin (TBIL) \>2\*ULN, ALT \>3\*ULN or AST \>3\*ULN and TBIL \>2\*ULN at any time were reported.
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Timepoint [5]
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Up to 28 days after study treatment discontinuation (Up to12 years)
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Primary outcome [6]
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Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation
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Assessment method [6]
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Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were \<=80 grams/Liter (g/L), \<=100g/L, decrease from baseline \>=20 g/L, and decrease from baseline \>=50 g/L.
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Timepoint [6]
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Up to 28 days after treatment discontinuation (Up to 12 years)
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Eligibility
Key inclusion criteria
* Signed informed consent prior to initiation of any study-mandated procedure.
* Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
* Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Any major violation of protocol AC 055 302/SERAPHIN.
* Pregnancy or breast-feeding.
* AST and/or ALT > 3 times the upper limit of the normal range.
* 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.
* Known hypersensitivity to ACT 064992 or any of the excipients.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/10/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/12/2020
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Sample size
Target
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Accrual to date
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Final
550
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Recruitment in Australia
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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The Alfred Hospital - Melbourne
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Royal Brisbane Hospital - Sunshine Coast
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2010 - Darlinghurst
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3004 - Melbourne
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Recruitment postcode(s) [3]
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4558 - Sunshine Coast
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Actelion
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Ethics approval
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Summary
Brief summary
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
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Trial website
https://clinicaltrials.gov/study/NCT00667823
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Trial related presentations / publications
Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12. Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/23/NCT00667823/Prot_000.pdf
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https://cdn.clinicaltrials.gov/large-docs/23/NCT00667823/SAP_001.pdf
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