UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035004 |
|---|---|
| Receipt number | R000039469 |
| Scientific Title | Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2020/11/26 18:52:46 |
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Basic information
Public title
Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure
Acronym
Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
Scientific Title
Phase I/IIa investigator-initiated multicenter single-arm open-label study of the safety and efficacy of intravenous HUCV002-01 in patients with chronic heart failure
Scientific Title:Acronym
Phase I/IIa single-arm open-label study of intravenous HUCV002-01 in patients with chronic heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety of HUCV002-01, a-GalCer expressed dendritic cells derived from autologous monocytes from patients with chronic heart failure within 24 weeks after the administration of the first dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The rate of adverse events
Key secondary outcomes
The rate of cell processing failure
Assessment of cardiac function
Evaluation of exercise tolerability
Clinical events due to the progression of heart failure
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
| Maneuver |
Interventions/Control_1
Peripheral monocytes will be collected from patients by apheresis on 9 to 58 before the first dose of HUCV002-1. The collected monocytes will be cultured and HUCV002-1 will be produced. The patient will be treated with the two doses of intravenous HUCV002-1 (Day1,7) as inpatients. The safety and efficacy of HUCV002-1 will be evaluated within 24 weeks after the first dose.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients diagnosed with chronic heart failure
2)20 years old or older, 80 years or younger at the time of informed consent
3)LVFT<40% by ECHO performed within 28 days before the enrollment
4)NYHA class II-IV, AND, no changes at least 4 weeks prior to the enrolment
5)BNP>=100 pg/mL (except for patients with NYHA class II)
6)Refractory to standard medical therapy on Guidelines for Acute/Chronic heart failure (2017) with no clinical improvement
7)Patients who has ability to understand and sign the informed consent
Key exclusion criteria
Those who has any of the following at the time of enrollment should be excluded.
1)Chronic heart failure dues to operable valvular disease or congenital cardiac disease
2)Awaiting cardiac transplant
3)Acute myocardial infarction within 28 days prior to the enrollment
4)Cerebrovascular disease within 28 days before the enrollment
5)Coronary artery revascularization (CAVG, PCI) was performed or planned within 3 months before getting consent or during the clinical study
6)New treatments for cardiac failure was started within 3 months before the enrollment
7)Patients with malignancy or history of malignant diseases within 1 year prior to the study (Except for those who had cured carcinoma in situ or intramucosal carcinoma)
8)Uncontrolled hypertension (systemic BP>160mmHg or diastolic BP>100mmHg)
9)Symptomatic hypotension
10)Autoimmune disease
11)Any of the following within 7 days before the registration
a)Hepatic dysfunction: AST > 90 U/L or ALT (male) > 126 U/L, (female) >69 U/L
b)Renal dysfunction: eGFR < 15 mL/min/1.73m2
c)Platelet counts < 100 x 10^3/uL
d)Hb < 9.0 g/dL
12)Positive for any of HBV, HCV, HIV, HTLV1 or syphilis within 56 days before the enrollment
13)Those who has history or viral hepatitis
14)Patients with uncontrolled active infection
15)Allergic to streptomycin or gentamicin
16)Allergic to animals (pig, sheep, cow) or cows milk
17)Patient who needs systemic steroid or immunosuppressive drugs
18)BSA > 2.0 m2 (Du Bois)
19)Functional gait disorder
20)Pregnant, lactating, or possible pregnant female. Female who wants to become pregnant or male who wants his partner to become pregnant. Those who refuses contraception during the study.
21)Those who participated in other clinical studies within 28 days prior to getting the informed consent. Those who plans to participate in other clinical studies during this study.
22)Patients whom the PI or investigators decided as inappropriate for the study.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Kyushu University Hospital
Division name
Cardiology
Zip code
Address
3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5357
htsutsui@cardiol.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Ide |
Organization
Kyushu University Hospital
Division name
Cardiology
Zip code
Address
3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL
092-642-5357
Homepage URL
tomomi_i@cardiol.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
九州大学病院（福岡県）、北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 03 | 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
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 27 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039469
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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