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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028521
Receipt No. R000032636
Scientific Title A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis
Date of disclosure of the study information 2017/08/03
Last modified on 2019/09/20

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Basic information
Public title A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis
Acronym A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis
Scientific Title A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis
Scientific Title:Acronym A Phase 1/2 Study of ADR-001 in Patients with Liver Cirrhosis
Region
Japan

Condition
Condition Decompensated Liver Cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a Phase 1/2 study in patients with liver cirrhosis caused by hepatitis C or nonalcoholic steatohepatitis. The safety and preliminary efficacy are evaluated in Phase 1, and the recommended dose for Phase 2 is determined. The exploratory efficacy and safety are investigated in Phase 2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Phase 1
・Safety

Phase 2
・Change of Child-Pugh score
Key secondary outcomes Phase 1
・Change of Child-Pugh score
・Improvement rate of Child-Pugh score
・Improvement rate of Child-Pugh grade

Phase 2
・Safety
・Improvement rate of Child-Pugh score
・Improvement rate of Child-Pugh grade

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
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Single dose of ADR-001, adipose-derived mesenchymal stem cell, is administered one of 3 doses intravenously. Safety and efficacy are evaluated 24 weeks after administration.
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

Not applicable
Gender Male and Female
Key inclusion criteria ・Men and women >= 20 years of age
・Chronic hepatitis C or NASH
・Child-Pugh grade B liver cirrhosis
・ECOG Performance Status <= 2
Key exclusion criteria ・Liver cirrhosis patients other than hepatitis C or NASH
・Malignant neoplasm (except hepatocellular carcinoma patients without recurrence more than 2 years)
・History of venous thrombosis or pulmonary embolism
・Serum creatinine >= 2 mg/dL or T-Bil >= 5.0 mg/dL
・Infection with hepatitis B, HIV, ATLV-1 or parvovirus B19
・Patients experienced transplantation or cell therapy
・Pregnancy or positive on pregnancy test
・Complications of significant heart disease, kidney disorder, or respiratory disease
・Drug or alcohol abuse
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Shuji
Middle name
Last name Terai
Organization Niigata University Medical & Dental Hospital
Division name Division of Gastroenterology and Hepatology
Zip code 951-8520
Address 754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata 951-8510
TEL 025-223-6161
Email adr-001@rohto.co.jp

Public contact
Name of contact person
1st name Contact for clinical study information
Middle name
Last name Contact for clinical study information
Organization Rohto Pharmaceutical Co., Ltd.
Division name Contact for clinical study information
Zip code 105-0022
Address 20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, Japan 105-0022
TEL 03-6832-6014
Homepage URL http://www.med.niigata-u.ac.jp/in3/medical/clinical%20LC.html
Email adr-001@rohto.co.jp

Sponsor
Institute Rohto Pharmaceutical Co., Ltd.
Institute
Department

Funding Source
Organization Rohto Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor N/A
Name of secondary funder(s) N/A

IRB Contact (For public release)
Organization Institutional Review Board of Niigata University Medical & Dental Hospital
Address 754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
Tel 025-223-6161
Email Chiken7@med.niigata-u.ac.jp

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 新潟大学院医歯学総合病院(新潟県)、日本大学医学部附属板橋病院(東京都)、北里大学病院(神奈川県)、大阪大学医学部附属病院(大阪府)、近畿大学医学部附属病院(大阪府)、徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 03 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 05 Month 08 Day
Date of IRB
2007 Year 06 Month 27 Day
Anticipated trial start date
2017 Year 07 Month 20 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 03 Day
Last modified on
2019 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032636

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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