UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief 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)
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	Yoshiki Sawa
Organization	Osaka University Hospital
Division name	Cardiovascular surgery
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	kazuotamada
Organization	Terumo Corporation
Division name	Clinical Development Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 23 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011618