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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031658
Receipt No. R000036156
Scientific Title An Observational Follow-Up Study of Patients Previously Enrolled in ADR-001-01 Study Against Liver Cirrhosis
Date of disclosure of the study information 2018/03/09
Last modified on 2019/03/11

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Basic information
Public title An Observational Follow-Up Study of Patients Previously Enrolled in
ADR-001-01 Study Against Liver Cirrhosis
Acronym An Follow-Up Study of Liver Cirrhosis
Scientific Title An Observational Follow-Up Study of Patients Previously Enrolled in
ADR-001-01 Study Against Liver Cirrhosis
Scientific Title:Acronym An Follow-Up Study of Liver Cirrhosis
Region
Japan

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

Objectives
Narrative objectives1 This is a follow-up study to assess safety and preliminary clinical activity of
ADR-001 in patients with liver cirrhosis (Child-Pugh score; Grade B) caused
by Hepatitis C or Nonalcoholic Steatohepatitis. Patients who have already
participated in the ADR-001-01 study and completed the last evaluation after 24
weeks of administration will be eligible to this study.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Safety
Key secondary outcomes ・Change of Child-Pugh score
・Improvement rate of Child-Pugh score
・Improvement rate of Child-Pugh grade

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1)Liver cirrhosis patients enrolled in ADR-001-01 study and completed the
last observation of the study
2)Voluntary signed informed consent
Key exclusion criteria 1)Patients evaluated by investigators as inappropriate
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Terai
Organization Niigata University Medical & Dental Hospital
Division name Division of Gastroenterology and Hepatology
Zip code
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
Middle name
Last name Contact for clinical study information
Organization Rohto Pharmaceutical Co., Ltd.
Division name Contact for clinical study information
Zip code
Address 20th Floor Shiodome Building 1-2-20 Kaigan, Minato-ku, Tokyo, Japan 105-0022
TEL 03-6832-6014
Homepage URL
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

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

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 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)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 09 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
2018 Year 01 Month 04 Day
Date of IRB
2018 Year 02 Month 27 Day
Anticipated trial start date
2018 Year 03 Month 09 Day
Last follow-up date
2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Continuous observation from 24 weeks to 24 months after the administration of ADR - 001 in the preceding study, conduct long - term safety assessment and exploratory evaluation of effectiveness.

Management information
Registered date
2018 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036156

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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