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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035004
Receipt No. R000039469
Official scientific title of the study 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 2018/11/26

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Basic information
Official scientific title of the study 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
Title of the study (Brief title) 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 drugs 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 Hiroyuki Tsutsui
Organization Kyushu University Hospital
Division name Cardiology
Address 3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5357
Email htsutsui@cardiol.med.kyushu-u.ac.jp

Public contact
Name of contact person Tomomi Ide
Organization Kyushu University Hospital
Division name Cardiology
Address 3-1-1 Maidashi,Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5357
Homepage URL
Email tomomi_i@cardiol.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 08 Month 31 Day
Anticipated trial start date
2018 Year 12 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039469

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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