UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018289 |
|---|---|
| Receipt number | R000021168 |
| Scientific Title | Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy |
| Date of disclosure of the study information | 2015/07/14 |
| Last modified on | 2020/03/09 13:16:08 |
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Basic information
Public title
Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Acronym
Safety Study of CNT-01 in Patients with Idiopathic TGCV
Scientific Title
Phase I/IIa Study of CNT-01 in Patients with Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Scientific Title:Acronym
Safety Study of CNT-01 in Patients with Idiopathic TGCV
Region
| Japan |
Condition
Condition
Idiopathic Triglyceride Deposit Cardiomyovasculopathy
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the safety and to examine the index of the efficacy after repeated dosing of CNT-01 in patients with idiopathic triglyceride deposit cardiomyovasculopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
-Adverse event
-Change in ECG parameters from Baseline (QTc, QT, QRS)
-Change in vital signs from Baseline (Body temperature, Blood pressure, Pulse rate)
-Change in clinical laboratory data from Baseline (Hematology, Serum chemistry, Urinalysis)
Key secondary outcomes
-Change in uptake and washout rate in BMIPP myocardial scintigraphy
-Change in blood concentration of fatty acid fraction from Baseline
-Change in lipase activity in peripheral polynuclear leucocyte from Baseline
-Change in blood lipoprotein fraction from Baseline (Total cholesterol in Chylomicron, VLDL, LDL, HDL, Triglyceride in Chylomicron, VLDL, LDL, HDL)
-Change in vacuolation rate in polynuclear leucocyte from Baseline
-Change in frequency in use of nitroglycerin from Baseline
-Change in New York Heart Association (NYHA) functional classification from
Baseline
-Change in vascular endothelial function from Baseline (Reactive hyperemic index)
-Change in score of SF-36 from Baseline
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients will receive CNT-01 500 mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
Interventions/Control_2
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Have a definite diagnosis of idiopathic triglyceride deposit cardiomyovasculopathy
2) After receiving a sufficient explanation upon participation in this study, on a full understanding, patients who obtained the written informed consent from each patient
3) More than 20 years old at the time of informed consent
4) Is able to oral intake
5) Must be willing to comply with protocol-required examination such as BMIPP myocardial scintigraphy
Key exclusion criteria
1) Have diabetic ketoacidosis
2) Have a malignancy that is being treated by anticancer drug or anticipated survival is less than three years
3) Female with pregnant or lactating
4) Is not able to agree to using intrauterine device, oral contraceptive, condom or having sexual intercourse from the start of taking investigational product to 30 days after the end of the study
5) Have a New York Heart Association functional classification IV
6) Have a known history of drug dependence
7) Is allergic to any component of the investigational product
8) Is allergic to BMIPP or iodine
9) Have a known history of clinically significant drug allergy
10) Have a severe liver dysfunction (Child classification B and C)
11) Participated in other clinical study within the past 3 months and received an investigational agent including placebo
12) Being treated with diet containing medium chain fatty acid
13) Is considered unfit for the study by the Investigator's medical decision
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Hirano |
Organization
Osaka University Grduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
6-2-3, Furuedai, Suita, Osaka 565-0874, JAPAN
TEL
+81-6-6872-8215
khirano@cnt-osaka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Nakatani |
Organization
Osaka University Hospital
Division name
Department of Medical Innovation
Zip code
Address
2-2, Yamadaoka, Suita, Osaka 565-0871, JAPAN
TEL
+81-6-6210-8289
Homepage URL
nakatani@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Ken-ichi Hirano, Department of Cardiovascular Medicine, Osaka University Grduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪大学医学部附属病院（大阪府） Osaka University Hospital(Osaka)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 14 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2020 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021168
