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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014395
Receipt No. R000016636
Scientific Title An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis
Date of disclosure of the study information 2014/07/01
Last modified on 2017/04/18

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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
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
Middle name
Last name Kiminori Kimura
Organization Tokyo metropolitan Komagome Hospital
Division name Division of Hepatology
Zip code
Address 3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
TEL 03-3823-2101
Email kkimura@cick.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiminori Kimura
Organization Tokyo metropolitan Komagome Hospital
Division name Division of Hepatology
Zip code
Address 3-18-22,Honkomagome ,Bunkyo-ku,Tokyo
TEL 03-3823-2101
Homepage URL
Email kkimura@cick.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
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 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 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 Completed
Date of protocol fixation
2014 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 12 Month 12 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2017 Year 04 Month 18 Day


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

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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