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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028965
Receipt No. R000033137
Scientific Title Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis
Date of disclosure of the study information 2017/09/20
Last modified on 2019/03/04

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Basic information
Public title Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis
Acronym Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis
Scientific Title Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related liver cirrhosis
Scientific Title:Acronym Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosis
Region
Japan

Condition
Condition Decompensated liver cirrhosis (Hepatitis C virus-related)
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to examine the safety and efficacy of transhepatic administration of autologous G-CSF mobilized peripheral blood CD34 positive cells compared with standard medical therapy in patients with hepatitis C virus-related liver cirrhosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Non-exacerbation rate of Child-Pugh score at 24 weeks after treatment
Key secondary outcomes 1) Child-Pugh Score
2) MELD Score
3) Ascites by abdominal ultrasonography and abdominal CT
4) Serum albumin, total protein, total bilirubin value and PT-INR
5) Serum hyaluronic acid and type-IV collagen
6) QOL evaluation by SF-36v2
7) Portal blood flow and velocity by abdominal ultrasonography
8) Death due to liver cirrhosis and all deaths
9) Onset of hepatocellular carcinoma
10) Performance and bugs of magnetic cell separation device

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 G-CSF administration(5 days), Apheresis, Transhepatic arterial administration of CD34 positive cells
Interventions/Control_2 Standard medical therapy
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) Patients with hepatitis C virus-related liver cirrhosis
2) Patients eligible for this study include those with hepatitis C virus-related decompensated liver cirrhosis with a Child-Pugh Score greater than or equal to 7 points in whom further improvement with current standard medical treatment is not expected at two points more than 90 days apart
3) Patients who aged 20 to 75 years
4) Patient who can give written informed consent themselves
Key exclusion criteria 1) Patients with HCV-related liver cirrhosis or cryptogenic liver cirrhosis
2) Patients who are positive for HBs-Ag, HIV-Ab, HTLV1-Ab, serological test for syphilis and HBc-Ab (CLIA method >10.00 S/CO)
3) Patients with alcoholic drinkers, Patients with a Child-Pugh Score less than or equal to 6 points in whom further improvement with abstinence for more than 6 months.
4) Patients complicated of malignant tumor or patients with a history of malignant tumor within 5 years (However, for patients with a history of intraepithelial carcinoma [e.g., colon mucosal cancer] and hepatocellular carcinoma, which are negative for AFP and PIVKA-II, is not excluded)
5) Total bilirubin> 5.0 mg/dL
6) Prothrombin time less than 30%
7) Serum creatinine> 2.0 mg/dL
8) Hemoglobin less than 8 g/dL
9) Platelet less than 20,000 / uL
10) Patients who have splenomegaly with longitudinal spleen diameter more than 15 cm by abdominal CT
11) Patients who have gastrointestinal bleeding or patients who may cause bleeding in the gastrointestinal tract
12) Patients with portal vein thrombosis
13) Patients currently suffering from or having a history of interstitial pneumonia
14) Patients with hematological disease (leukemia, myeloproliferative disease, myelodysplastic syndrome or sickle cell anemia)
15) Patients with autoimmune disease
16) Patients with less than 3 months since last episode of unstable angina, myocardial/cerebral infarction, Patients with less than 3 months since coronary artery/carotid artery/intracranial artery stenting
17) Patients with proliferative diabetic retinopathy
18) Patients with a history of severe allergic reactions or side effects to G-CSF, apheresis, or a contrast agents
19) Pregnant women, lactating women, patients who may be pregnant, female patients planning pregnancy during the study period
20) Any other reason that the Clinical Supervision or Clinical Researchers may have for considering a case unsuitable for the study
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Torimura
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka, Japan
TEL 0942-31-7561
Email tori@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Nakamura
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka, Japan
TEL 0942-31-7561
Homepage URL
Email ntoru@med.kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
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 関西医科大学附属病院(大阪府)
兵庫医科大学病院(兵庫県)
湘南鎌倉総合病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2017 Year 09 Month 20 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 20 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
2017 Year 09 Month 01 Day
Last modified on
2019 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033137

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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