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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00667823




Registration number
NCT00667823
Ethics application status
Date submitted
24/04/2008
Date registered
28/04/2008
Date last updated
10/07/2019

Titles & IDs
Public title
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
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
Secondary ID [1] 0 0
AC-055-303
Universal Trial Number (UTN)
Trial acronym
SERAPHIN OL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Arterial Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Macitentan

Experimental: ACT-064992 - ACT-064992


Treatment: Drugs: Macitentan
Tablet, oral administration, 10 mg dose once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with treatment-emergent Adverse Events (AEs) and serious AEs
Timepoint [1] 0 0
up to 28 days after study drug discontinuation, assessed for up to 55 months
Secondary outcome [1] 0 0
Number of subjects with AEs leading to premature discontinuation of study drug
Timepoint [1] 0 0
up to 28 days after study drug discontinuation, assessed for up to 55 months
Secondary outcome [2] 0 0
Occurrence of treatment-emergent liver function test (ALT and/or AST) abnormality - > 3 and = 5 × ULN; > 5 and = 8 × ULN; > 8 × ULN
Timepoint [2] 0 0
up to 28 days after study drug discontinuation, assessed for up to 55 months
Secondary outcome [3] 0 0
Occurence of treatment-emergent hemoglobin abnormality - = 8 g/dL; > 8 and = 10 g/dL
Timepoint [3] 0 0
up to 28 days after study drug discontinuation, assessed for up to 55 months

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.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Royal Brisbane Hospital - Sunshine Coast
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3181 - Melbourne
Recruitment postcode(s) [3] 0 0
4558 - Sunshine Coast
Recruitment outside Australia
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Alabama
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Arizona
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California
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Colorado
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Virginia
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Wisconsin
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Argentina
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Ciudad Autonoma
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Buenos Aires
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Cordoba
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Santa Fe
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Vienna
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Minsk
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Vitebsk
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Chiang Mai
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Khon Kaen
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Ukraine
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Dnepropetrovsk
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Lviv
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Ukraine
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Odessa
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Actelion
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00667823
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications