UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of tyrosine kinase inhibitors for the treatment of severe and progressive pulmonary hypertension
Title of the study (Brief title)	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	Ichizo Tsujino
Organization	Hokkaido University Hospital
Division name	Internal medicine I
Address	N14, W5, Sapporo, JAPAN
TEL	011-706-5911
Email	itsujino@med.hokudai.ac.jp

Public contact
Name of contact person	Ichizo Tsujino
Organization	Hokkaido University Hospital
Division name	Internal medicine I
Address	N14, W5, Sapporo, JAPAN
TEL	011-706-5911
Homepage URL
Email	itsujino@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital, Internal medicine I
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018244