Clinical Trial: Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Long Term, Single-arm, Open-label Extension Study of Protocol AC-055-305 to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome

Brief Summary: Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of Eisenmenger syndrome.

Detailed Summary:
Sponsor: Actelion

Current Primary Outcome:

• (Serious) treatment-emergent adverse events (AEs) [ Time Frame: 3 years ]
  Treatment-emergent (serious) AEs up to 30 days after study drug discontinuation
• Treatment-emergent marked laboratory abnormalities (MLAs) [ Time Frame: up to EOT ]
  Treatment-emergent marked laboratory abnormalities (MLA) of interest up to EOT
• Proportion of subjects with treatment-emergent ALT and/or AST abnormality [ Time Frame: up to EOT ]
  Proportion of subjects with treatment-emergent ALT and/orAST abnormality (> 3 and ≤ 5 x ULN; > 5 and ≤ 8 x ULN;> 8 x ULN) associated or not with total bilirubin ≥ 2 x ULN, up to EOT.

Original Primary Outcome: Assessment of the long-term safety and tolerability [ Time Frame: 3 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Actelion

Dates:
Date Received: November 29, 2012
Date Started: September 1, 2013
Date Completion: September 1, 2020
Last Updated: March 22, 2017
Last Verified: March 2017