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Clinical Trials/JPRN-jRCT2031180075
JPRN-jRCT2031180075SuspendedPhase 2

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

Egashira Kensuke0 sites12 target enrollmentStarted: January 10, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Suspended
Sponsor
Enrollment
12
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to <= 79age old (—)
Sex
All

Inclusion Criteria

  • •1) Patients with pulmonary hypertension classified as Dana Point group 1 and WHO functional class I to IV.
  • •Idiopathic pulmonary arterial hypertension (IPAH)
  • •Heritable pulmonary arterial hypertension (HPAH)
  • •Drug or toxin-induced pulmonary hypertension
  • •Pulmonary arterial hypertension associated with following diseases
  • •a) Connective tissue diseases
  • •b) Congenial heart diseases (at least 1 year has past after shunt repair at the baseline examinations)
  • •c) HIV infection
  • •2) Patients whose PAH is confirmed by right heart catheterization
  • •Mean pulmonary arterial pressure (mPAP) at rest is over than or equal to 25 mmHg
  • •Pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure is under 15mmHg
  • •3) Patients with over 240 dyn*sec/cm5 PVR at baseline right heart catherization
  • •4) Patients treated with over 2 of 3 types of drugs (prostacyclin analogue, endothelin receptor antagonist, phosphodiesterase-5 inhibitor) and stable over 90 days
  • •5) Over 20 and under 80 years old at the time of consent
  • •Patients with a possibility of pregnancy must confirm their non-pregnant status before administration of NK-104-NP and agree to avoid pregnancy at least 180 days by secure contraception methods. Women with no possibility of pregnancy are defined as women who are post-menopausal state (no menses over 1 year, infertility or post-sterilization state).
  • •6) Patients who have provided written informed consent with their signatures before procedures defined in the protocol.

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.

Investigators

Sponsor
Egashira Kensuke

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