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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033369
Receipt No. R000038025
Scientific Title Phase I / IIa clinical trial for patients with hepatitis C or B virus derived liver cirrhosis by CBP / beta catenin inhibitor PRI-724
Date of disclosure of the study information 2018/07/18
Last modified on 2019/01/10

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Basic information
Public title Phase I / IIa clinical trial for patients with hepatitis C or B virus derived liver cirrhosis by CBP / beta catenin inhibitor PRI-724
Acronym Phase I / IIa clinical trial for patients with hepatitis C or B virus derived liver cirrhosis by PRI-724
Scientific Title Phase I / IIa clinical trial for patients with hepatitis C or B virus derived liver cirrhosis by CBP / beta catenin inhibitor PRI-724
Scientific Title:Acronym Phase I / IIa clinical trial for patients with hepatitis C or B virus derived liver cirrhosis by PRI-724
Region
Japan

Condition
Condition HCV or HBV liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety and efficacy of PRI - 724 against HCV or HBV liver cirrhosis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I:
Serious side effect expression rate
Phase IIa:
Amount of change from the baseline in liver tissue fibrosis area ratio by liver biopsy at 12 weeks after administration
Key secondary outcomes Phase I:
(1) Adverse Event Expression Ratio
(2) Percentage of occurrence of side effects
(3) Pharmacokinetics
Phase IIa:
(1) Amount of change from measurement of liver stiffness by baseline from Fibro Scan at 12 weeks after administration
(2) Amount of change from baseline of Child-Pugh Score at 12 weeks after administration
(3) Amount of change from baseline for MELD score at 12 weeks after administration
(4) Change amount from baseline of modified Histological Activity Index (HAI) by liver biopsy at 12 weeks after administration

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 twice a week for 4 hours 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) Patients with liver cirrhosis caused by HCV or HBV that satisfies the following 1) or 2) and satisfies 3)
1) Patients with serum HCV-RNA positive or HCV antibody positive
2) Patients with serum HBV-DNA positive or HBs antigen positive
3) confirmed liver cirrhosis by liver biopsy performed in the screening period patients who received diagnosis
(2) Patients with Child-Pugh classification in A or B status
(3) Patients who satisfy HCV cirrhosis from 1) to 3), HBV cirrhosis 4)
In the case of HCV cirrhosis;
1) Patients who have not reached SVR * with DAA therapy
2) Patients who are difficult to implement DAA therapy
3) Patients who have been over 24 weeks after achieving SVR * with DAA or IFN therapy
In case of HBV cirrhosis;
4) Patients who have been at least 24 weeks since the start of administration of Nucleotide analogue
* SVR is SVR 12.
(4) Patients with Performance Status 0 to 2
(5) Patients aged 20 years or over and under 75 when acquiring informed consent
(6) Regarding participation in this trial (including liver biopsy), patients who obtained informed consent by their own voluntary intention
Key exclusion criteria (1) Patients with HCV and HBV co-infection, patients who came to cirrhosis due to causes other than HCV or HBV, or patients whose cause of cirrhosis is unknown
(2) Patients with esophageal gastric varices determined to be treated by endoscopic examination at screening
(3) Patients with complication or previous history of primary liver cancer
(4) Merger of malignant tumor or past patients (within 3 years before screening).
(5) Patients who can not be denied HIV, HTLV-1 or syphilis
(6) Serum creatinine value > ULN x 1.5
(7) Patients with poor control of diabetes, hypertension or heart failure
(8) Patients with psychiatric diseases judged to have the potential to influence the implementation of clinical trials
(9) Patients who have severe allergy to or contrast media
(10) Patients with HCV who have not passed the regulated period after treatment for HCV cirrhosis at registration.
(11) Patients whose dosage regimen was changed within 12 weeks prior to enrollment
(12) Patients who have history of drug or alcohol intoxication within 5 years before acquiring informed consent or who have history of drug or alcohol abuse within the past year
(13) Patients who participated in other clinical trials and clinical trials within 30 days prior to acquisition of consent, patients who used investigational drugs or investigational equipment
(14) Patients who received liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who are difficult to intravenously administer
(15) Patients whose liver biopsy is expected to be difficult to perform
(16) Patients who are pregnant or nursing, or who are likely to become pregnant
(17) Male patients who do not obtain consent to contraception from the time of acquiring informed consent until the end of 12 weeks after the administration of investigational drug
(18) In addition, patients investigated by investigators or clinical trial doctors as judged unsuitable for this trial
Target sample size 34

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, Japan
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, Japan
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
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2018 Year 07 Month 18 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 12 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038025

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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