PORtopulmonary Hypertension Treatment wIth maCitentan ─ a randOmized Clinical Trial

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 15-003160
    NCT ID: NCT02382016
    Sponsor Protocol Number: AC-055-404

About this study

24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Main Inclusion Criteria:

  • Male or female of at least 18 years of age
  • Confirmed diagnosis of portopulmonary hypertension

Main Exclusion Criteria:

  • Severe hepatic impairment
  • Severe obstructive or restrictive lung disease
  • Pulmonary veno-occlusive disease
  • Systolic blood pressure (SBP) < 90 mmHg at Screening
  • ALT/AST >= 3 x ULN
  • Bilirubin >= 3 mg/dL at Screening
  • Any known factor or disease that might interfere with treatment compliance, study conduct, or interpretation of results

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Closed for enrollment

Contact information:

Annette Mcnallan R.N.

(507) -5996

mcnallan.annette@mayo.edu

.
CLS-20178177

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