Status:
COMPLETED
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
3-12 years
Phase:
PHASE3
Brief Summary
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH...
Eligibility Criteria
Inclusion
- PAH diagnosis confirmed with right heart catheterization (RHC):
- Idiopathic or heritable PAH, or
- Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery) or
- PAH-Congenital Heart Disease (PAH-CHD) associated with systemic-to-pulmonary shunts (after global amendment dated 09 May 2012)
- World Health Organization functional Class (WHO FC) I, II or III
- Male or female ≥ 3 months and \< 12 years of age (maximum age at randomization is 11.5 years)
- Body weight ≥ 3.5 kg
- Peripheral oxygen saturation (SpO2) ≥ 88% (at rest, on room air)
- Baseline PAH-therapy (Calcium channel blocker, bosentan, prostanoid, phosphodiesterase type-5 inhibitor) if present, has to be stable for at least 3 months prior to screening. During the study, all background treatments should remain stable
- Signed informed consent by the parents or legal representatives
Exclusion
- PAH etiologies other than listed above
- Non-stable disease status
- Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost
- Systolic blood pressure \< 80% of the lower limit of normal range
- Aspartate aminotransferase and/or alanine aminotransferase values \> 1.5 times the upper limit of normal range.
- Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- Hemoglobin and/or hematocrit levels \< 75% of the lower limit of normal range.
- Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet
- Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:
- Glibenclamide (glyburide)
- Cyclosporin A
- Sirolimus
- Tacrolimus
- Fluconazole
- Rifampicin (rifampin)
- Ritonavir
- Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
- Endothelin receptor antagonists (ERAs) other than bosentan
- Treatment with another investigational drug within 1 month prior to randomization or planned treatment
Key Trial Info
Start Date :
March 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2013
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01223352
Start Date
March 8 2011
End Date
August 19 2013
Last Update
February 4 2025
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