UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015319 |
|---|---|
| Receipt number | R000017767 |
| Scientific Title | The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome |
| Date of disclosure of the study information | 2014/10/12 |
| Last modified on | 2014/10/02 13:05:10 |
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Basic information
Public title
The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome
Acronym
The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome
Scientific Title
The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome
Scientific Title:Acronym
The efficacy of dabigatran for portal vein thrombosis/Budd-Chiari syndrome
Region
| Japan |
Condition
Condition
Portal vein thrombosis or Budd-Chiari syndrome
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to elucidate the effect of dabigatran on portal vein thrombosis or Budd-Chiari syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Therapeutic effect of dabigatran on portal vein thrombosis or Budd-Chiari syndrome
Key secondary outcomes
1) Safety of dabigatran for portal vein thrombosis or Budd-Chiari syndrome
2) Predictive factors for the therapeutic effect of dabigatran on portal vein thrombosis or Budd-Chiari syndrome
3) Comparison of therapeutic effect between warfarin and dabigatran for portal vein thrombosis or Buddd-Chiari syndrome
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dabigatran
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) patients with portal vein thrombosis or Budd-Chiari syndrome diagnosed by radiological findings
2) patients who is scheduled for, or receiving anticoagulant therapy for portal vein thrombosis or Budd-Chiari syndrome
Key exclusion criteria
1) patients with Child-Pugh classification C
2) patients with severe cardiac or pulmonary dysfunction
3) patients with hemoglobin A1c > 6.5
4) patients with treatment history of dabigatran
5) patients who need treatment of dabigatran combined with other anticoagulant or antiplatelet agent
6) patients with creatinine clearance < 50 ml/min
7) patients who have bleeding symptom or hemophliac
8) patients with peptic ulcers
9) patients with history of cerebral bleeding within 6 months
10) patients with epidural catheter
11) patients with use of non-steroidal anti-inflammatory drugs
12) patients with use of P-glycoprotein repressor
13) patients with use of itoraconazole
14) patients using cardiac pacemaker
15) pregnant woman
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Nephrology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
043-222-7171
maru-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Maruyama |
Organization
Chiba University Graduate School of Medicine
Division name
Gastroenterology and Nephrology
Zip code
Address
1-8-1, Inohana, Chuou-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
maru-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School of Medicine, Department of Gastroenterology and Nephrology
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 10 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 02 | Day |
Last modified on
| 2014 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017767
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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