This study evaluates the effects of VI-0106 (an extended-release formulation of tacrolimus) in participants with pulmonary arterial hypertension (PAH) who continue to have functional limitations despite being on optimized background PAH therapy. Participants will be randomly assigned with equal chance to receive either VI-0106 or placebo in a double-blind fashion to assess whether VI-0106 improves outcomes in this population.
WHO Group 1 PH: Pulmonary Arterial Hypertension;
WHO functional class II - IV despite optimized treatment with one or more modalities. Treatments for PAH must be stable for at least 3 months at the time of screening;
Right heart catheterization (RHC) at screening (or within 3 months prior to screening);
Screening 6MWD >75 meters to ≤450 meters.
PAH due to pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
Chronic thromboembolic or portopulmonary hypertension
Total Lung Capacity (TLC) <60% predicted;
FEV1/FVC <70% predicted or FEV1 <60% predicted;
Parallel
VI-0106
DrugTacrolimus Extended-Release Capsules
Placebo
DrugInactive oral capsule
Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24
Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24
Time to clinical worsening defined as a composite of the following events:
* All-cause death; * In-patient hospitalization for PAH or right-sided heart failure; * Worsening-related placement on a recipient list for heart-lung or lung transplantation; * Diminished functional capacity (decrease from baseline 6MWD of ≥15% with an absolute value of at least 22 meters and a ≥1 category worsening of WHO functional class); * Worsening-related need to initiate rescue therapy with an approved PAH therapy, or the need to increase the dose of an IV prostacyclin infusion by 10% or more.
Time to clinical worsening by a restricted definition comprised of all-cause death and in-patient hospitalization for PAH or right-sided heart failure
Change from baseline in 6MWD at Week 28
This trial is not recruiting at the moment. You can still explore other options:
