UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031658 |
|---|---|
| Receipt number | 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 | 2024/03/14 15:25:08 |
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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
27
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
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
adr-001@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical Co., Ltd.
Institute
Department
Personal name
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
Institutional Review Board of Niigata University Medical & Dental Hospital
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
Tel
025-223-6161
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）、大阪大学医学部附属病院（大阪府）、北里大学病院（神奈川県）、徳島大学病院（徳島県）、旭川医科大学病院（北海道）、広島大学病院（広島県）
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
19
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
| 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
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 15 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 04 | Day |
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
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036156
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| Registered date | File name |
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