UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014891 |
|---|---|
| Receipt number | R000017313 |
| Scientific Title | An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy |
| Date of disclosure of the study information | 2014/08/20 |
| Last modified on | 2022/07/15 14:45:59 |
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Basic information
Public title
An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy
Acronym
An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy
Scientific Title
An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy
Scientific Title:Acronym
An Open-Label Phase I Follow-up Study on Patients with HCV-induced Cirrhosis who received treatment with PRI-724 to observe Safety and Efficacy
Region
| Japan |
Condition
Condition
Hepatitis C virus-induced cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess safety and efficacy of patients with HCV-induced cirrhosis who received PRI-724 treatment by 12-months observation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events and adverse drug reactions (including subjective symptoms and abnormal laboratory values)
Key secondary outcomes
(1)Incidence rate of liver cancer
(2)Child-Pugh Score
(3)Liver biopsy
(4)Serum albumin level
(5)Serum fibrosis marker level(s)
(6)Ascitic fluid level
(7)Improvement rate of lower leg edema
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who were eligible to 1101-study criteria and received PRI-724 treatment with written informed consent signed and dated.
(2) Having provided voluntary written consent for participation in this study.
Key exclusion criteria
(1)Female patients who are pregnant or suspected to be pregnant.
(2) Male patients who do not consent to using reliable contraception methods for 12 weeks after the end of infusion of PRI-724 in 1101 study.
(3)Patients contraindicated for liver biopsy.
Unless the patients were found to be contraindicated for liver biopsy after receiving PRI-724 in 1101 study.
(4) Patients who were enrolled in other clinical study other than 1101-study within 30 days prior the consent.
(5) 1101-study termination with follow-up failure due to pass-away or other reasons.
(6) Patients judged by investigators ineligible due to seriousness of patients condition.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kiminori |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo metropolitan Komagome Hospital
Division name
Division of Hepatology
Zip code
113-8677
Address
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
TEL
03-3823-2101
kiminori_kimura@tmhp.jp
Public contact
Name of contact person
| 1st name | Kiminori |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo metropolitan Komagome Hospital
Division name
Division of Hepatology
Zip code
113-8677
Address
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
TEL
03-3823-2101
Homepage URL
kiminori_kimura@tmhp.jp
Sponsor or person
Institute
Tokyo metropolitan Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
PRISM Pharma Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komagome Hospital Institutional Review Board
Address
3-18-22,Honkomagome ,Bunkyo-ku,Tokyo,Japan
Tel
03-3823-2101
km_koma_chiken@tmhp.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT02828254
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
26-0459
Institutions
Institutions
東京都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 07 | Month | 20 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 21 | Day |
Other
Other related information
Adverse events (AEs) and Adverse reactions are to be stratified by AEs, cohorts, or Child-Pugh category.
Management information
Registered date
| 2014 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017313
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
