UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015696 |
|---|---|
| Receipt number | R000018244 |
| Scientific Title | Safety and efficacy of tyrosine kinase inhibitors for the treatment of severe and progressive pulmonary hypertension |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2018/11/26 16:33:24 |
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Basic information
Public title
Safety and efficacy of tyrosine kinase inhibitors for the treatment of severe and progressive pulmonary hypertension
Acronym
Safety and efficacy of TKI for severe progressive PH
Scientific Title
Safety and efficacy of tyrosine kinase inhibitors for the treatment of severe and progressive pulmonary hypertension
Scientific Title:Acronym
Safety and efficacy of TKI for severe progressive PH
Region
| Japan |
Condition
Condition
pulmonary hypertension
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety, tolerability and efficacy of tyrosine kinase inhibitors (imatinib or sorafenib) for the patients with treatment-resistant and progressive severe pulmonary hypertension
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety (adverse events due to the use of tyrosine kinase inhibitor)
Key secondary outcomes
Efficacy to pulmonary hypertension
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 tyrosine kinase inhibitors
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. 20 years old or older at the time of obtaining informed consent
2. WHO-functional class 3 or 4
3. Treated according to the latest guidelines for the management of pulmonary hypertension
4. Symptoms/signs being worsening regardless of the optimal treatment
5. Considered to be tolerable to imatimib or sorafenib administration, or already being treated by either of imatimib or sorafenib
6. Written informed consent obtained
Key exclusion criteria
1. Those to whom imatinib and sorafenib are contraindicated
2. Those to whom the principle investigator deemed to be unsuitable for enrollment
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichizo Tsujino |
Organization
Hokkaido University Hospital
Division name
Internal medicine I
Zip code
Address
N14, W5, Sapporo, JAPAN
TEL
011-706-5911
itsujino@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ichizo Tsujino |
Organization
Hokkaido University Hospital
Division name
Internal medicine I
Zip code
Address
N14, W5, Sapporo, JAPAN
TEL
011-706-5911
Homepage URL
itsujino@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital, Internal medicine I
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 17 | 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
| 2014 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 14 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018244
