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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
N/A
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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
Recruitment state(s)
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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/ct2/show/NCT00667823
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00667823
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