UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008289 |
|---|---|
| Receipt number | R000009762 |
| Scientific Title | Study of new therapy in patients with chronic hepatitis C including liver cirrhosis |
| Date of disclosure of the study information | 2012/07/02 |
| Last modified on | 2015/12/28 15:10:45 |
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Basic information
Public title
Study of new therapy in patients with chronic hepatitis C including liver cirrhosis
Acronym
Study of new therapy in patients with chronic hepatitis C including liver cirrhosis
Scientific Title
Study of new therapy in patients with chronic hepatitis C including liver cirrhosis
Scientific Title:Acronym
Study of new therapy in patients with chronic hepatitis C including liver cirrhosis
Region
| Japan |
Condition
Condition
chronic hepatitis C and liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal safety and efficacy of thrombopoietin (TPO) on improving liver function in patients with chronic hepatitis C and liver cirrhosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
serum albumin concentration
Key secondary outcomes
Child-Pugh Score, platelet count, hyarulonic acid, prothrombin time, serum bilirubin, serum cholinesterase
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
To investigate the optimal dosage of TPO
To administer the optimal dosage of TPO for 24 weeks
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) Participant who gave written informed consent
(2) Outpatient
(3) Chronic hepatitis C and liver cirrhosis patient with liver dysfunction under SVR after treatment with PEG-INF plus Ribavirin
(4) Chronic hepatitis C and liver cirrhosis patient who had no response to PEG-INF plus Ribavirin and who passed 4 weeks after the treatment
(5) Chronic hepatitis C and liver cirrhosis patient who can't receive PEG-INF treatment due to thrombopenia
(6) Platelet count is 30 to 70 thousands/microl.
(7) Serum albumin is 2.5 to 4.0g/dl.
(8) Chronic hepatitis C and liver cirrhosis patient with liver dysfunction in previous half year
(9) Child-Pugh score is 8 or under
Key exclusion criteria
(1) Patient with acute hepatitis
(2) Patient with severe liver dysfunction whose serum liver function test is 5 fold higher than normal range, especially, AST or ALT is 2 fold higher than normal range
(3) HIV patient
(4) Patient with shunt from portal vein to inferior vena cava
(5) Serum total bilirubin concentration is more than 3.0 mg/dl
(6) Past history of severe stroke or severe heart disease
(7) Bone marrow transplantation recipient or patients with immunodeficiency
(8) Patient with IgA or other plasma protein deficiency
(9) Patient with severe pulmonary, renal, gastroenterology, hematology or psycho-neurologic disease
(10) Serum HbA1c concentration is more than 8.0 (NGSP)
(11) Patient with hepatocellular carcinoma or another malignancy
(12) Woman with pregnancy or willing to get pregnant
(13) Patient who received platelet transfusion in previous 2 weeks
(14) Patient who are administered albumin preparation in previous 6 months
(15) Past history of splenectomy or partial splenic embolization
(16) Past history of drug allergies
(17) Past history of thromboembolism
(18) Patient whose doctor determined as inadequate for the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ohkohchi |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3181
nokochi3@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Ohkohchi |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Surgery
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3181
Homepage URL
nokochi3@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）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 02 | 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
| 2012 | Year | 06 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 08 | Day |
Date trial data considered complete
| 2015 | Year | 10 | Month | 27 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 28 | Day |
Last modified on
| 2015 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009762
