UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver disease
Acronym	PVTED study
Scientific Title	Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver disease
Scientific Title:Acronym	PVTED study
Region	Japan

Condition
Condition	Portal vein thrombosis
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the usefulness of edexaban tosilate hydrate for portal vein thrombosis associated with chronic liver disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction rate of portal vein thrombus 14 days after edoxaban administration
Key secondary outcomes	Safety of edoxaban administration against portal vein thrombosis

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	Edoxaban 30 to 60 mg / day for 14 days
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Clinically (histologically or imagewise) diagnosed as chronic liver disease. 2) Patients who have been confirmed to have thrombus in the portal vein, superior mesenteric vein, or / and splenic vein on the image. 3) The latest inspection value within 14 days before registration (same day as two weeks before the registration day is acceptable) satisfies all of the following. Hemoglobin 9.0 g / dl or more (male), 8.0 g / dl or more (female) Platelet count 50,000 / mm 3 or more Creatinine clearance 30 ml / min or more 4) Child-Pugh classification A or B. 5) Weight 40 kg or more. 6) About participation in the examination Informed consent is obtained from the patient himself.
Key exclusion criteria	1. Child-Pugh classification C. 2. Endoscopic examination confirms the presence of lesions at risk of gastrointestinal bleeding (esophageal gastric varices, gastric / duodenal ulcers, gastric antral vascular dilation, etc.), and does not perform prophylactic treatment. 3. Have active malignancy. 4. Patients taking anticoagulant or / and antiplatelet drugs. 5. Patients with a history of clear bleeding symptoms such as cerebral haemorrhage. 6. Patients who weigh less than 40 kg at registration. 7. A woman who is pregnant or has a possibility of pregnancy, within 28 days after childbirth or breast-feeding. A man who wishes to become a partner's pregnant. 8. Mental illness or psychiatric symptoms are merged and it is judged that participation in the examination is difficult. 9. It has severe hypersensitivity to the ingredients of Edoxaban. 10. Because of drug allergy, neither CT nor MRI using a contrast agent can be performed. 11. Others, the doctor in charge determines that participation in this examination is inappropriate.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shuichi Kaneko
Organization	Kanazawa University Hospital
Division name	Gastroenterology / Hepatobiliary and pancreatic surgery
Zip code
Address	13-1,Takara-machi,Kanazawa city
TEL	076-265-2000
Email	skaneko@m-kanazawa.jp

Public contact
1st name of contact person	1st name Middle name Last name Hajime Takatori
Organization	Kanazawa University Hospital
Division name	Gastroenterology
Zip code
Address	13-1,Takara-machi,Kanazawa city
TEL	076-265-2000
Homepage URL
Email	takatori@m-kanazawa.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University Hospital
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
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	2017 Year 11 Month 24 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	2017 Year 10 Month 26 Day
Date of IRB	2017 Year 12 Month 12 Day
Anticipated trial start date	2017 Year 12 Month 18 Day
Last follow-up date	2019 Year 05 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	2017 Year 11 Month 24 Day
Last modified on	2019 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034376