UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030108 |
|---|---|
| Receipt number | 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 20:23:22 |
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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
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
takatori@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034376
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
