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An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis

NCT02195440 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-07-07

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.

Conditions

  • Hepatitis C Virus-infected Cirrhosis

Interventions

DRUG

PRI-724

10 - 160 mg/m2, 7 days CIV (in the vein) with 7 days rest per one cycle. Number of Cycles: 6.

Sponsors & Collaborators

  • Prism Pharma Co., Ltd.

    collaborator INDUSTRY

  • Japan Agency for Medical Research and Development

    collaborator OTHER_GOV

  • Komagome Hospital

    lead OTHER

Principal Investigators

  • Kiminori Kimura, MD · Komagome Metropolitan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195440 on ClinicalTrials.gov