UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025776 |
|---|---|
| Receipt number | R000029353 |
| Scientific Title | Predictors for therapeutic effect of Lusutrombopag in chronic liver disease |
| Date of disclosure of the study information | 2017/01/20 |
| Last modified on | 2020/07/27 08:50:09 |
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Basic information
Public title
Predictors for therapeutic effect of Lusutrombopag in chronic liver disease
Acronym
Predictors of Lusutrombopag
Scientific Title
Predictors for therapeutic effect of Lusutrombopag in chronic liver disease
Scientific Title:Acronym
Predictors of Lusutrombopag
Region
| Japan |
Condition
Condition
Chronic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the predictors for therapeutic effect of Lusutrombopag in chronic liver ddisease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate (more than 50,000 /mm^3) at after adminstraion of lusutrombopag.
Key secondary outcomes
1.Increase rate of Platelet count.
2.Correlation with increase rate and thrombopoietin.
3.Correlation with increase rate and megakaryocyte.
4.Correlation with increase rate and portal hypertention.
5.Adverse event occurrence rate.
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
Multicenter, single-arm, open-label trial
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.Platelet count<50*10^9/L in liver cirrhosis patient.
2.age >20
3.patients received a fully described on the basis of informed consent document
Key exclusion criteria
1.Patients with a hematologic malignancy.
2.Active malignancy at time of study entry except HCC.
3.Patients who underwent liver transplantation
4.Patients with a severe liver dysfunction (Child-pugh C)
5.Patients with a medical history of thrombosis.
6.Patients with a medical history of thrombotic disease adult patients.
7.Women who are pregnant or breastfeeding
8.Severe GI bleeding.
9.Not appropriate for this study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
272-0822
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
042-778-8390
kiruha@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
2252-0375
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
042-778-8390
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
a
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
Tel
042-778-8111
rinrib@med.kitasato-u.ac.jp
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 | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | 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 | 01 | Month | 20 | Day |
Last modified on
| 2020 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029353
