UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2016 Year 10 Month 03 Day
Date of IRB	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2019 Year 03 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	2016 Year 10 Month 20 Day
Last modified on	2020 Year 04 Month 27 Day

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