UMIN-CTR Clinical Trial

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
Email	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
Email	kiminori_kimura@tmhp.jp

Sponsor
Institute	Tokyo metropolitan Komagome Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017313