Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertensio

Phase 2

• Conditions: Pulmonary arterial hypertension

• Registration Number: JPRN-UMIN000032531
• Lead Sponsor: Japan Agency for Medical Research and Development (AMED)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with malignancy or undergone surgeries due to malignancy within 5 years. 2) Patients taking statins and can NOT stop them from 3 days before administration of NK-104-NP. 3) Patients taking fibrates and can NOT stop them from 3 days before administration of NK-104-NP. 4) Patients taking cyclosporine. 5) Patients with severe cardiac dysfunction or heart failure (<30% ejection fraction or NYHA class III or over). 6) Patients with untreated severe arrhythmia except symptomatically stable patients with pacemaker or drug therapy. 7) Patients after prosthetic valve replacement (except biomaterials). 8) Patients with acute hepatitis, fulminant hepatitis or progressive liver dysfunction. 9) Patients with moderate or severe liver dysfunction (who can NOT satisfy following criteria) associated with chronic hepatitis etc. except patients with liver cirrhosis. a) AST/ALT is within 3 times upper limit of shared reference range, b) serum bilirubin is 2 times upper limit of shared reference range. 10) Patients with liver cirrhosis and Child B(moderate) or C(severe) liver dysfunction. 11) Patients with obvious interstitial pneumonia. 12) Patients with biliary atresia. 13) Patients with CK(CPK) elevation over 3 times upper limit of shared reference range. 14) Patients with past-history of hypersensitivity or severe adverse effects by pitavastatin calcium. 15) Patients with severe drug allergy or adverse effects including anaphylactic shock. 16) Patients with alcohol abuse or drug addiction. 17) Patients in other trials at the time of informed consent or patients less than 16 weeks after termination of other test drugs. 18) Patients with pregnancy, patients with a possibility of pregnancy and breast-feeding women. 19) Patients judged to be inappropriate as a candidate of this trial by principal investigator or subinvestigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of pulmonary vascular resistance (PVR) between baseline and day 84

Secondary Outcome Measures

Name	Time	Method
Effectiveness: changes of following values between baseline and Day 84 Mean right atrial pressure (mPAP) at rest Mean pulmonary arterial pressure (mPAP) Cardiac output (CO) Cardiac index (CI) Pulmonary vascular resistance index (PVRI) Total pulmonary resistance (TPR) Mixed venous oxygen saturation (SvO2) Distance of 6 minutes walk Modified Borg index WHO functional class NT-proBNP concentration NOx concentration Total pulmonary resistance index(TPRI) Systemic vascular resistance index (SVRI) Pulmonary vascular resistance (PVR) Safety: Incidences of following events Adverse effects Severe adverse effects Side effect