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Not yet recruiting NCT07612657

A Phase 3 Study of Extended-release Tacrolimus in Subjects With Pulmonary Arterial Hypertension and Functional Limitations

Phase III Interventional Pulmonary Arterial Hypertension Pulmonary Arterial Hypertension (PAH) Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH) Pulmonary Arterial Hypertension PAH

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VI-0106, Placebo.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension, Pulmonary Arterial Hypertension (PAH), Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH), Pulmonary Arterial Hypertension PAH. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Double-blind, Placebo-controlled, Safety and Efficacy Study of VI-0106 (Extended-release Tacrolimus) in Subjects With PAH and Functional Limitations Despite Optimized Treatment With Available PAH Medications

Overview

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.

Interventions

  • Drug VI-0106
    Tacrolimus Extended-Release Capsules
  • Drug Placebo
    Inactive oral capsule

Primary outcome measures

  • Change from baseline in 6MWD (6 Minute Walk Distance) at Week 24 [Time frame: Baseline to Week 24]
Secondary outcome measures (4)
  • Percentage of subjects with a ≥1 category improvement vs baseline in WHO functional class at Week 24 [Time frame: Baseline to Week 24]
  • Time to clinical worsening defined as a composite of the following events: [Time frame: Baseline to Week 52]
  • Time to clinical worsening by a restricted definition comprised of all-cause death and in-patient hospitalization for PAH or right-sided heart failure [Time frame: Baseline to Week 52]
  • Change from baseline in 6MWD at Week 28 [Time frame: Baseline to Week 28]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Evidence of left-sided heart disease;
  • Inability to safely attempt completion of the 6MWD;
  • Life expectancy <6 months;
  • eGFR <30 mL/min/1.73 m2 (CKD-EPI equation);
  • Moderate to severe hepatic dysfunction (Child-Pugh score >10);
  • Serum potassium >5.1 mEq/L;
  • Use of experimental PAH treatments within the past 3 months;
  • Active infection requiring antibiotic, antifungal, or antiviral therapies;
  • Current systemic treatment with cyclosporine;
  • Known allergy or hypersensitivity to tacrolimus;
  • Significant psychiatric, addictive, or other disorder that compromises the subject's ability to provide informed consent, follow study protocol, or adhere to study treatment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07612657 · PH-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗