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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032531
Receipt No. R000037101
Scientific Title Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension
Date of disclosure of the study information 2018/09/01
Last modified on 2019/05/10

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Basic information
Public title Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension
Acronym Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertension
Scientific Title Multi-center, investigator-initiated trial of repeated intravenous administration of NK-104-NP in patients with pulmonary arterial hypertension
Scientific Title:Acronym Investigator-initiated trial of repeated administration of NK-104-NP in patients with pulmonary hypertension
Region
Japan

Condition
Condition Pulmonary arterial hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Explore effective and safety dose of NK-104-NP containing 2,4 or 8 mg pitavastatin calcium after 4 days repeated intravenous administration in patients with pulmonary arterial hypertension and examine pharmacokinetics in plasma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Change of pulmonary vascular resistance (PVR) between baseline and day 84
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 NK-104-NP 2 mg, 4 days
Interventions/Control_2 NK-104-NP 4 mg, 4 days
Interventions/Control_3 NK-104-NP 8 mg, 4 days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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.
Key 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.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Kensuke
Middle name
Last name Egashira
Organization Pharmaceutical Sciences Kyushu University
Division name Department of Translational Medicine
Zip code 8128582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 JAPAN
TEL 092-642-4649
Email j-koga@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Jun-ichiro
Middle name
Last name Koga
Organization Kyushu University Hospital
Division name Division of Angiocardiology
Zip code 812-8582
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582 JAPAN
TEL 092-642-4649
Homepage URL
Email j-koga@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Japan Agency for Medical Research and Development (AMED)
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The University of Tokyo Hospital
Address Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
Tel 03-5800-8743
Email IRBjimu-tokyo@umin.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部付属病院、岡山大学病院、神戸大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 03 Month 20 Day
Date of IRB
2018 Year 02 Month 26 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037101

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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