UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024496 |
|---|---|
| Receipt number | 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 | 2020/04/27 10:19:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mkurata@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028193
