A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrentMedDRA version: 21.1Level: LLTClassification code 10068739Term: Chronic thromboembolic pulmonary hypertensionSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-002823-41-AT
- Lead Sponsor
- Actelion Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 280
1. Signed and dated Informed Consent Form.
2. Male and female subjects =18 (or the legal age of consent in the jurisdiction in which the study is taking place) and =85 years old at Screening (Visit 1).
3. Subjects with diagnosis of CTEPH and inoperability confirmed by the corresponding adjudication committee (AC; country-specific adjudication committee [CSAC] or central adjudication committee [CAC]), defined as one of the following options:
a) Inoperable CTEPH (ie, technically non-operable) with:
– Diagnosis of CTEPH based on at least two of the following assessments performed in the 14-month period prior to randomization (Visit 2): ventilation/perfusion (V/Q) scan; pulmonary angiography (PA); computed tomography pulmonary angiogram (CTPA) and/or magnetic resonance angiography (MRA).
– RHC (and LHC, if needed) 1 performed at least 90 days after start of full anticoagulation showing: PVR at rest = 400 dyn.sec/cm5 or = 5 Wood units for the hemodynamic cohort and PVR at rest = 300 dyn.sec/cm5 or =3.75 Wood units for the non-hemodynamic cohort; (mPAP) = 25 mmHg; Pulmonary arterial wedge pressure (PAWP) = 15 mmHg or, if not available or unreliable, a left ventricular end diastolic pressure (LVEDP) = 15 mmHg.
b) Persistent/recurrent CTEPH after BPA, with:
– Diagnosis of CTEPH based on at least one of the following assessments performed in the 14-month period prior to randomization (Visit 2) and after last interventional (BPA) treatment: V/Q scan, PA, CTPA or MRA.
– RHC (and LHC, if needed) 1 performed at least 90 days after last interventional (BPA) treatment and at least 90 days after start of full anticoagulation, showing: PVR at rest = 400 dyn.sec/cm5 or = 5 Wood units for the hemodynamic cohort and PVR at rest = 300 dyn.sec/cm5 or =3.75 Wood units for the non-hemodynamic cohort; mPAP = 25 mmHg; PAWP = 15 mmHg, or, if not available or unreliable, an LVEDP = 15 mmHg.
c) Persistent/recurrent CTEPH after PEA (including PEA followed by BPA) with:
– Diagnosis of CTEPH based on at least one of the following assessments performed in the 14-month period prior to randomization (Visit 2) and after last surgical (PEA) or interventional (BPA) treatment: V/Q scan, PA, CTPA or MRA.
-RHC (and LHC, if needed) 1 performed at least 90 days after last surgical (PEA) or interventional (BPA) treatment and at least 90 days after start of full anticoagulation, showing: PVR at rest = 400 dyn.sec/cm5 or 5 Wood units for the hemodynamic cohort and PVR at rest = 300 dyn.sec/cm5 or =3.75 Wood units for the non-hemodynamic cohort; mPAP = 25 mmHg; PAWP = 15 mmHg, or, if not available or unreliable, an LVEDP = 15 mmHg.
4. PH in WHO FC I–IV.
5. Subject able to perform the 6MWT with a minimum distance of 100 m and a maximum distance of 450 m at screening visit (Visit 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98
General exclusion criteria:
1. Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
2. 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.
3. Known concomitant life-threatening disease with a life expectancy < 12 months.
Exclusion criteria related to the disease:
4. Planned BPA within 26 weeks after randomization.
5. Change in dose or initiation of new PH-specific therapy within 90 days prior to the baseline RHC (and LHC, if needed) qualifying for enrollment for the hemodynamic cohort and within 90 days prior to randomization (Visit 2) for the non-hemodynamic cohort.
6. Treatment with prostacyclin (epoprostenol), prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e., selexipag/Uptravi) within 90 days prior to randomization (Visit 2), except those given at vasodilator testing during RHC.
7. Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to baseline RHC (and LHC, if needed).
Exclusion criteria related to comorbidities:
8. Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc).
9. Other as per selexipag Summary of Product Characteristics (SmPC).
Exclusion criteria related to selexipag use:
10. As per selexipag Summary of Product Characteristics (SmPC).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method