An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis - An open label, single arm, dose escalation phase 1 trial of PRI-724 in patients with HCV-induced cirrhosis

Tokyo metropolitan Komagome Hospital0 sites16 target enrollmentJuly 1, 2014

ConditionsHepatitis C virus-induced cirrhosis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatitis C virus-induced cirrhosis
Sponsor: Tokyo metropolitan Komagome Hospital
Enrollment: 16
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 1, 2014

End Date

August 8, 2016

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Tokyo metropolitan Komagome Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

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 /\µL. (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.