Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension

• Register: EUCTR
• Last refreshed on: 14 June 2021
• Main ID: EUCTR2007-003694-27-DE
• Date of registration: 12/12/2007
• Prospective Registration: Yes
• Primary sponsor: Actelion Pharmaceuticals Ltd
• Public title: Clinical research to assess the long-term safety and tolerability of ACT-064992 in patients with Pulmonary Arterial Hypertension
• Scientific title: SERAPHIN-OL: Study with an ERA in Pulmonary arterial Hypertension to Improve cliNical outcome (Open Label) Long-term single-arm open-label extension study of the SERAPHIN study, to assess the safety and tolerability of macitentan/ACT 064992 in patients with symptomatic pulmonary arterial hypertension - SERAPHIN-OL
• Date of first enrolment: 28/10/2008
• Target sample size: 700
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003694-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States

Contacts

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

• Name: Global Medical Information
• Affiliation: Actelion Pharmaceuticals Ltd

Key inclusion & exclusion criteria

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 morbidity event and for whom a written approval to roll
over into this study has been obtained from the Sponsor.
• Men or women = 12 years of age:
Only sites that have adequate pediatric pulmonary experience are allowed to enroll
patients between 12 and 17 year of age.
• Women of childbearing potential* with a negative pre-treatment serum
pregnancy test and who consistently and correctly use (from screening and up to
28 days after study treatment discontinuation) a reliable method of contraception
with a Pearl index of < 1% (oral hormonal contraceptive, implant, vaginal
hormone ring, or intrauterine system [IUS]). During the entire study duration
and for at least 1 month after last study drug intake, your partner, if not
vasectomised, must use a condom in addition.
*A woman is considered to have childbearing potential unless she meets at least one of
the following criteria:
- previous bilateral salpingo-oophorectomy or hysterectomy,
- premature ovarian failure confirmed by a specialist gynecologist,
- pre-pubescence, XY genotype, Turner syndrome, uterine agenesis,
- age > 50 years and not treated with any kind of HRT for at least 2 years
prior to screening with amenorrhea for at least 24 consecutive months
prior to screening and a serum FSH level of > 40 IU/L at screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 513
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 79

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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

symptomatic pulmonary arterial hypertension
MedDRA version: 17.1 Level: PT Classification code 10064911 Term: Pulmonary arterial hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Intervention(s)

Product Name: macitentan
Product Code: ACT-064992
Pharmaceutical Form: Tablet
INN or Proposed INN: macitentan
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Main Objective: To assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic pulmonary arterial hypertension (PAH).

Primary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary Objective: N/A

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

AC-055-303

2007-003694-27-GB

Source(s) of Monetary Support

Actelion Pharmaceuticals Ltd

Ethics review

Status: Approved
Approval date: 28/10/2008
Contact: