UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020543 |
|---|---|
| Receipt number | R000023718 |
| Scientific Title | Efficacy of imatinib for the treatment of pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis |
| Date of disclosure of the study information | 2016/01/13 |
| Last modified on | 2019/01/29 13:14:57 |
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Basic information
Public title
Efficacy of imatinib for the treatment of pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Acronym
Efficacy of imatinib for the treatment of pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Scientific Title
Efficacy of imatinib for the treatment of pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Scientific Title:Acronym
Efficacy of imatinib for the treatment of pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Region
| Japan |
Condition
Condition
pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of imatinib for patients with pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy (Time to clinical worsening)
Key secondary outcomes
Safety
Efficacy (Median survival)
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
| Medicine |
Interventions/Control_1
Oral administration of imatinib
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are diagnosed with pulmonary veno-occlusive disease/pulmonary capillary hemangiomatosis and treated at the principal investigator's institution
Patients who are 18 years or older at the time of giving their written consent
Key exclusion criteria
Patients with a contraindication to imatinib
Patients who were considered as inadequate for enrollment by the principal investigator
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Matsubara |
Organization
National Hospital Organization Okayama Medical Center
Division name
Departments of Cardiology and Clinical Science
Zip code
Address
1711-1 Tamasu, Kita-ku, Okayama, JAPAN
TEL
086-294-9911
himatsu@okayamamc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Matsubara |
Organization
National Hospital Organization Okayama Medical Center
Division name
Departments of Cardiology and Clinical Science
Zip code
Address
1711-1 Tamasu, Kita-ku, Okayama, JAPAN
TEL
086-294-9911
Homepage URL
himatsu@okayamamc.jp
Sponsor or person
Institute
National Hospital Organization Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2016 | Year | 01 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
