Phase 4 N=85 Randomized Quadruple-blind Treatment

PORtopulmonary Hypertension Treatment wIth maCitentan - a randOmized Clinical Trial

Portopulmonary Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT02382016 ↗

Enrolled (actual)

Serious AEs

22.2%

Results posted

Nov 2018

Primary outcome: Primary: Relative Change From Baseline to Week 12 in Pulmonary Vascular Resistance (PVR). — 0.63; 0.98 ratio — p=0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Macitentan (Drug); Placebo (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Actelion
Primary completion: Oct 2017

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

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02382016). 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.