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Clinical Trial Summary

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


Clinical Trial Description

This is a single-center, open-label, continuous i.v. administration, dose escalation Phase I study in patients with hepatitis C cirrhosis. One cycle consisted of one-week continuous i.v. administration of PRI-724 followed by a one-week observation period. One cohort was a total of six cycles, a 12-week treatment period. PRI-724 was administered at a dose of 10 mg/m2/day in Cohort 1, 40 mg/m2/day in Cohort 2, and 160 mg/m2/day in Cohort 3 in a dose escalation manner. Each cohort was to include 6 subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02195440
Study type Interventional
Source Komagome Hospital
Contact
Status Completed
Phase Phase 1
Start date August 2014
Completion date March 31, 2017

See also
  Status Clinical Trial Phase
Completed NCT02828254 - A Follow-up Evaluation Study of PRI-724-1101