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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000030108
Receipt No. R000034376
Scientific Title Clinical study on the usefullness of edoxaban tosilate hydrate to portal vein thrombosis complicated with chronic liver disease
Date of disclosure of the study information 2017/11/24
Last modified on 2019/05/27

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000034376

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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