UMIN-CTR Clinical Trial

Basic information
Public title	An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis
Acronym	An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis
Scientific Title	An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis
Scientific Title:Acronym	An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis
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 investigate safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Adverse events and adverse drug reactions (including subjective symptoms and abnormal laboratory values)
Key secondary outcomes	(1)Child-Pugh Score (2)Liver biopsy: Histology Activity Index (HAI) (3)Serum albumin level (4)Serum fibrosis marker level(s) (5)Ascitic fluid level (6)Improvement rate of lower leg edema (7)Pharmacokinetics

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous intravenous administration for a week continuous intravenous administration of PRI-724
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) Presence of cirrhosis due to hepatitis C virus. 1) Serum HCV-RNA test positive 2) Definitive diagnosis of cirrhosis established by liver biopsy (HAI score: Grade IV-D). (2)Child-Pugh Class A or B at the time of informed consent, with no likelihood of improvement with existing medical treatment. (3)Performance Status: 0 - 2. (4)Between =>20 and <75 years of age at the time of providing written consent. (5)Having provided voluntary written consent for participation in this study. (6)Esophageal and gastric varices are well controlled
Key exclusion criteria	(1)Patients with cirrhosis due to causes other than hepatitis C virus; or patients with cirrhosis due to unknown causes. (2)Patients with a history of primary liver cancer or a complication thereof. (3)Patients with a complication of malignant tumor or a history thereof (within 5 years prior to screening). (4)Patients in whom such active viral infections as HBV, HIV or ATCL or syphilis infection cannot be ruled out. (5)Patients with serum creatinine >1.5 times over upper normal or creatinine clearance =<60 mL/min/1.73 m2. (6)Patients with hemoglobin <8 g/dL. (7)Patients with platelet count <50,000 /&micro;L. (8)Patients with T.Bil =>3.0 mg/dL. (9)Patients with a complication of poorly controlled diabetes, hypertension or heart failure. (10)Patients with a complication of mental disorder requiring treatment. (11)Patients with serious allergy to contrast media or a history thereof. (12)Patients with allergy to inactive ingredients of the study drug. (13)Patients who have received interferon, ribavirin or anti-HCV agents within 12 weeks before registration in this study. (14)When the medical treatment to a primary disease is carried out, Patient who was changed the dosage and administration within the 12 weeks before registration. (15)Patients with a history of drug or alcohol addiction within five years at the time of providing written consent or a history of drug or alcohol abuse within the past one year. (16)The patient who received a liver transplant or other organ transplants (a bone marrow transplantation is included), and the patient for whom intravenous administration and venous access are difficult. (17)Patients contraindicated for liver biopsy. (18)Female patients who are pregnant or suspected to be pregnant; or those who desire to get pregnant during the study period or those of childbearing potential. (19)Male patients who do not consent to practice birth control during the clinical study.
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Kiminori Middle name Last name Kiminori 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	NCT02195440
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW	20-0458

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 07 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	16
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 18 Day
Anticipated trial start date	2014 Year 07 Month 16 Day
Last follow-up date	2016 Year 08 Month 08 Day
Date of closure to data entry
Date trial data considered complete	2016 Year 12 Month 12 Day
Date analysis concluded	2017 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2014 Year 06 Month 27 Day
Last modified on	2022 Year 07 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016636