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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024496
Receipt No. R000028193
Scientific Title Clinical trial of a new treatment for the hepatocellular carcinoma patients with liver cirrhosis
Date of disclosure of the study information 2016/11/01
Last modified on 2016/12/27

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Basic information
Public title Clinical trial of a new treatment for the hepatocellular carcinoma patients with liver cirrhosis
Acronym Clinical trial of a new treatment for the hepatocellular carcinoma patients with liver cirrhosis
Scientific Title Clinical trial of a new treatment for the hepatocellular carcinoma patients with liver cirrhosis
Scientific Title:Acronym Clinical trial of a new treatment for the hepatocellular carcinoma patients with liver cirrhosis
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We investigate the Eltrombopag antifibrotic and antitumor effects on the hepatocellular carcinoma patients with liver cirrhosis and thrombocytopenia, who have no indication for resection, RFA, TACE or Sorafenib.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes progression free survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Multiple administration of the optimal dosage
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
75 years-old >
Gender Male and Female
Key inclusion criteria (1) Between age of 20 to 75, who have agreement
(2) Outpatients
(3) Cirrhotic patients without uncontrollable ascites, who has no indication for resection, RFA, TACE or Sorafenib
(4) Platelet counts less than 70,000/microL
(5) Patient with the abnormal values in liver function tests (Alb, ALT, ChE, T-Bil, D-Bil) 6-month prior to registration
(6) Less than four points of JIS score
Key exclusion criteria (1) Acute hepatitis
(2) Patients with HIV infection
(3) Patients with a past history of cerebrovascular disease or cardiovascular disease
(4) Bone marrow transplant recipients and immunosuppressed patients
(5) Patient with plasma protein deficiency (eg. IgA deficiency)
(6) Patients complicated with cerebrovascular disease, cardiovascular disease, pulmonary disease, renal disease, gastroenterological disease, hematological disease, and neurological or psychiatric disease
(7) Patients with a cancer in other organs
(8) Patients with HbA1c(NGSP) higher than 8.0
(9) Patients who is currently pregnant or consider pregnancy prior to the study
(10) Patients who participated in another clinical trial within 6 months and received medications having pharmacologic effects on improving liver function or increasing platelet counts
(11) Patients who have taken or who is currentry taking thrombopoietic agent
(12) Patients with a past history of taking the Eltrombopag
(13) Patients with allergic reaction to this medicine
(14) Patients with allergic reaction to other medications
(15) Patients with a past history of arterial or venous thromboembolism
In addition, the patient who is judged to be inappropriate for this study
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ohkohchi Nobuhiro
Organization University of Tsukuba
Division name Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
Address 1-1-1, Tennnodai, Tsukuba, Ibaraki, JAPAN
TEL 029-853-3221
Email nokochi3@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kurata Masanao
Organization University of Tsukuba
Division name Department of Gastrointestinal and Hepato-Biliary-Pancreatic Surgery
Zip code
Address 1-1-1, Tennnodai, Tsukuba, Ibaraki
TEL 029-853-3221
Homepage URL
Email mkurata@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
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
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 筑波大学附属病院(茨城県) University of Tsukuba Hospital

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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
2016 Year 10 Month 20 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028193

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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