TerminatedPhase 2

Long-term Extension Study of the Safety and Pharmacokinetics of QCC374 in PAH Patients

Stopped: Study was terminated early for strategic reasons. Only Part I of the study was completed.

United States, Germany, United Kingdom5 participantsStarted 2018-02-01

Plain-language summary

This is a long-term open-label safety extension to the Phase 2a study of inhaled QCC374 in adult patients with PAH. This study provides the patients who completed the QCC374X2201 study with the option to continue receiving QCC374. The study will monitor the long-term safety, tolerability and efficacy of QCC374 in patients with PAH.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Written informed consent must be obtained before any assessment is performed. * Subject was enrolled in the QCC374X2201 study and completed per protocol Exclusion Criteria: * Subjects who have started receiving prostacyclin (epoprostenol), prostacyclin analogs (i.e. trepostinil, iloprost, beraprost) or prostacyclin receptor agonists (i.e. selexipag) since the last study drug intake in the QCC374X2201 study. * Females who are pregnant, or who plan to become pregnant during the study, or who are breastfeeding * Any known factor or disease that may interfere with treatment compliance or study conduct (i.e. drug or alcohol dependence) * Subjects who withdrew consent from the study QCC374X2201

What they're measuring

Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) in Patients With PAH Over a Two Year Period

Timeframe: Two years

Trial details

NCT IDNCT02939599

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-11-06

Results submitted2019-11-01

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials