UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014395
Receipt number 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 2022/07/04 18:13:41

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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 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 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

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

Value
https://center6.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