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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009926
Receipt No. R000011618
Scientific Title Exploratory clinical study to investigate safety and efficacy of TCD-51073 in patients with with Severe Heart Failure due to Chronic ischemic Heart Disease.(follow-up study)
Date of disclosure of the study information 2013/02/01
Last modified on 2016/08/05

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Basic information
Public title Exploratory clinical study to investigate safety and efficacy of TCD-51073 in patients with with Severe Heart Failure due to Chronic ischemic Heart Disease.(follow-up study)
Acronym Exploratory clinical study to investigate safety and efficacy of TCD-51073 in patients with with Severe Heart Failure due to Chronic ischemic Heart Disease.(follow-up study)
Scientific Title Exploratory clinical study to investigate safety and efficacy of TCD-51073 in patients with with Severe Heart Failure due to Chronic ischemic Heart Disease.(follow-up study)
Scientific Title:Acronym Exploratory clinical study to investigate safety and efficacy of TCD-51073 in patients with with Severe Heart Failure due to Chronic ischemic Heart Disease.(follow-up study)
Region
Japan

Condition
Condition Severe heart failure due to chronic ischemic heart disease
Classification by specialty
Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patient with severe heart failure, to investigate safety and efficacy of TCD-51073 for two years after transplantation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival rate for two years after transplantation.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) Patients who are are enrolled in the first clinical study and complete examination and observation at the 26th week of transplantation.
2) Patients who live in Japan for two years after transplantation.
3) Patients who sign written informed consent prior to the clinical study.
Key exclusion criteria 1) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University Hospital
Division name Cardiovascular surgery
Zip code
Address 2-15 Yamadaoka, Suita-shi, Osaka, Japan
TEL 06-6879-6090
Email shiken@hp-crc.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name kazuotamada
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address 1500, Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa
TEL 0465-81-4104
Homepage URL
Email Michio_Satou@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 Completed
Date of protocol fixation
2012 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study after the first trial

Management information
Registered date
2013 Year 02 Month 01 Day
Last modified on
2016 Year 08 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011618

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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