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
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
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
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
