UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009926
Receipt number 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 12:36:26

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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 or person

Institute

Terumo Corporation

Institute

Department

Personal name



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

Value
https://center6.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