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

Japan Agency for Medical Research and Development (AMED)0 sites12 target enrollmentSeptember 1, 2018

ConditionsPulmonary arterial hypertension

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Pulmonary arterial hypertension
Sponsor: Japan Agency for Medical Research and Development (AMED)
Enrollment: 12
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 1, 2018

End Date

March 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Japan Agency for Medical Research and Development (AMED)

Eligibility Criteria

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.