A Follow-up Evaluation Study of PRI-724-1101 | NCT02828254

Studies
A Follow-up Evaluation Study of PRI-724-1101

NCT02828254

Sponsor

Komagome Hospital

Status

Completed

Last Update Posted

Jul 7, 2022Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Hepatitis C Virus-infected Cirrhosis

Interventions

PRI-724

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000014891	Other Identifier	UMIN (University Hospital Medical Information) CTR

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 18, 2014Actual

Primary Completion Date

Mar 27, 2017Actual

Completion Date

Jan 31, 2018Actual

First Submitted Date

Jun 15, 2016

First Submission Date that Met QC Criteria

Jul 6, 2016

First Posted Date

Jul 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2022

Last Update Posted Date

Jul 7, 2022Actual

Name	Class
Prism Pharma Co., Ltd.	INDUSTRY
Japan Agency for Medical Research and Development	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study To evaluate the safety and efficacy of PRI-724 administration in patients with cirrhosis due to hepatitis C by 12-month follow-up.

Detailed Description

This is a single-center, nonintervention, open-label, observational study in subjects who received the study drug (identification code: PRI-724) in Study 1101 to follow up the safety and disease condition of cirrhosis after administration for 12 months.

In Study 1101, one cycle consisted of 2 weeks with one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. Treatment with a total of six cycles (duration of treatment, 12 weeks) was performed.

In this study, the subjects in each cohort in Study 1101 (PRI-724 dose: Cohort 1, 10 mg/m2/day; Cohort 2, 40 mg/m2/day; Cohort 3, 160 mg/m2/day) were followed up and observed for 12 months after administration.

In Study 1101, target number of subjects was 6 subjects in each cohort, a total of 18 subjects. However, the number of registered subjects was 7 subjects in Cohort 1, 7 subjects in Cohort 2, and 2 subjects in Cohort 3, a total of 16 subjects. Safety analysis set was 6 subjects, 6 subjects, and 2 subjects, respectively, a total of 14 subjects. Target number of the subjects in this study was the same as that in Study 1101; however, of the subjects in Study 1101, 5 subjects in Cohort 1 and 3 subjects in Cohort 2 consented to participate in this study (Study 1102).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Name	Type	Description	Arm Group Labels	Other Names
PRI-724	Drug			CBP-beta-catennin inhibitor OP-724

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety: Incidences of adverse events and adverse drug reactions	The data will be aggregated by each adverse events, cohort and Child-Pugh score	12 months after completion of the clinical trial, PRI-724-1101

Secondary Outcomes

Measure	Description	Time Frame
Incidence of liver cancer	The data will be aggregated by each cohort and Child-Pugh score	12 months after completion of the clinical trial, PRI-724-1101
Child-Pugh Score	The data will be aggregated by each cohort and Child-Pugh score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having been administered PRI-724 in Study 1101 after being confirmed to meet the inclusion criteria and not to meet the exclusion criteria and consenting to participate in the study.
Having provided voluntary written consent for participation in this study.

Exclusion Criteria:

Patients who are pregnant or may be pregnant, or who desire to become pregnant or may be pregnant during the clinical study [excluding patients who have undergone a sterilization procedure or postmenopausal patients (if amenorrhea without medical reasons continues more than 12 months), patients who are nursing.
Patients who do not consent to practice birth control during the clinical study (including male patients).
Patients with serious allergy to contrast media or a history thereof.
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.
Patients contraindicated for liver biopsy. However, this criterion will not apply to a patient who has turned out to be contraindicated for liver biopsy after having been administered PRI-724 in Study 1101.
Patients who participated in another clinical trial, except PRI-724-1101 trial, within 30 days at the time of providing written consent.
Patients who have discontinued administration of PRI-724 in Study 1101 due to death or other reasons and become lost for follow-up.
Other, at the point when Study 1101 has been completed (or discontinued), patients who are judged inappropriate for inclusion in the study by the investigator for such reasons as the presence of serious pathological condition.](streamdown:incomplete-link)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

PRI-724 administration in patients with cirrhosis due to hepatitis C

Sampling Method

Probability Sample