Phase 4
Completed N=85
PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial
Portopulmonary Hypertension
Source: ClinicalTrials.gov NCT02382016 ↗
Enrolled (actual)
85
Serious AEs
22.2%
Results posted
Nov 2018
Primary outcomePrimary: Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). — 0.63; 0.98 ratio — p=0.0001
◆ Published Evidence
Highly cited
182citations · ~26 / year
Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial.
Summary
24-week study to evaluate the efficacy and safety of macitentan for the treatment of portopulmonary hypertension.
Linked Publications (2)
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Macitentan for the treatment of portopulmonary hypertension (PORTICO): a multicentre, randomised, double-blind, placebo-controlled, phase 4 trial.
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PORTICO: First Randomized Controlled Trial of Vasomodulator Therapy in Portopulmonary Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). |
0.63; 0.98 | 0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in 6-minute Walk Distance (6MWD) |
385.8; 383.2; 392.2; 380.8; 6.4; -2.4 | 0.4264 |
| SECONDARY Change From Baseline to Week 12 in WHO Functional Class (FC) |
1; 1; 27; 23; 15; 18 | 0.1278 |
| SECONDARY Change From Baseline to Week 12 in the Biomarker N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) |
0.86; 1.04 | 0.3951 |
| SECONDARY Change From Baseline to Week 12 in Mean Right Atrial Pressure (mRAP) |
7.3; 6.7; 9.0; 7.0; 1.6; 0.3 | 0.0637 |
| SECONDARY Change From Baseline to Week 12 in Mean Pulmonary Artery Pressure (mPAP) |
46.4; 43.8; 40.0; 44.2; -6.4; 0.4 | 0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in Cardiac Index |
3.1; 2.9; 3.7; 3.0; 0.6; 0.1 | 0.0009 sig |
| SECONDARY Change From Baseline to Week 12 in Total Pulmonary Resistance (TPR) |
689.3; 671.5; 489.4; 653.1; -199.8; -18.3 | 0.0001 sig |
| SECONDARY Change From Baseline to Week 12 in Mixed Venous Oxygen Saturation (SVO2) |
69.2; 69.9; 70.3; 70.7; 1.1; 0.8 | 0.9844 |
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) = 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
Data sourced from ClinicalTrials.gov (NCT02382016) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.