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Recruitment status Completed
Unique ID issued by UMIN UMIN000008289
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email nokochi3@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009762


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