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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020543
Receipt No. 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

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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
Email 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
Email himatsu@okayamamc.jp

Sponsor
Institute National Hospital Organization Okayama Medical Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023718

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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