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

NCT02828254 | Completed DMC

• 2 other identifiers: PRI-724-1102UMIN000014891
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Virus-infected Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 (7)

• Incidence of liver cancer

  12 months after completion of the clinical trial, PRI-724-1101

• Child-Pugh Score

  12 months after completion of the clinical trial, PRI-724-1101

• Liver biopsy (Only in applicable patients)

  12 months after completion of the clinical trial, PRI-724-1101

• Serum albumin level

  12 months after completion of the clinical trial, PRI-724-1101

• Serum fibrosis marker level(s)

  12 months after completion of the clinical trial, PRI-724-1101

Interventions

PRI-724 DRUG

Also known as: CBP-beta-catennin inhibitor, OP-724

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may not qualify if:

• Having provided voluntary written consent for participation in this study.
• 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.

Sponsors & Collaborators

• Komagome Hospital: lead
• Prism Pharma Co., Ltd.: collaborator
• Japan Agency for Medical Research and Development: collaborator

Study Sites (1)

Tokyo metropolitan Komagome Hospital

Tokyo, Japan

Location

MeSH Terms

Interventions

ICG 001

Study Officials

• Kiminori Kimura, MD

  Komagome Metropolitan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: July 11, 2016
• Study Start: December 18, 2014
• Primary Completion: March 27, 2017
• Study Completion: January 31, 2018
• Last Updated: July 7, 2022

Record last verified: 2022-07

Locations

JP (1)