Status:
COMPLETED
An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis
Lead Sponsor:
Komagome Hospital
Collaborating Sponsors:
Prism Pharma Co., Ltd.
Japan Agency for Medical Research and Development
Conditions:
Hepatitis C Virus-infected Cirrhosis
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the safety and tolerability of PRI-724 in patients with HCV-induced cirrhosis.
Detailed 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. administrati...
Eligibility Criteria
Inclusion
- Presence of cirrhosis due to hepatitis C virus. 1) Serum HCV-RNA test positive 2) Definitive diagnosis of cirrhosis established by liver biopsy (HAI score: Grade IV-D).
- Child-Pugh Class A or B at the time of informed consent, with no likelihood of improvement with existing medical treatment.
- Performance Status: 0 - 2.
- Between =\>20 and \<75 years of age at the time of providing written consent.
- Having provided voluntary written consent for participation in this study.
- Esophageal and gastric varices are well controlled
Exclusion
- Patients with cirrhosis due to causes other than hepatitis C virus; or patients with cirrhosis due to unknown causes.
- Patients with a history of primary liver cancer or a complication thereof.
- Patients with a complication of malignant tumor or a history thereof (within 5 years prior to screening).
- Patients in whom such active viral infections as HBV, HIV or ATCL or syphilis infection cannot be ruled out.
- Patients with serum creatinine \>1.5 times over upper normal or creatinine clearance =\<60 mL/min/1.73 m2.
- Patients with hemoglobin \<8 g/dL.
- Patients with platelet count \<50,000 /\µL.
- Patients with T.Bil =\>3.0 mg/dL.
- Patients with a complication of poorly controlled diabetes, hypertension or heart failure.
- Patients with a complication of mental disorder requiring treatment.
- Patients with serious allergy to contrast media or a history thereof.
- Patients with allergy to inactive ingredients of the study drug.
- Patients who have received interferon, ribavirin or anti-HCV agents within 12 weeks before registration in this study.
- 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.
- 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.
- 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.
- Patients contraindicated for liver biopsy.
- 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.
- Male patients who do not consent to practice birth control during the clinical study.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT02195440
Start Date
August 1 2014
End Date
March 31 2017
Last Update
July 7 2022
Active Locations (1)
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1
Tokyo metropolitan Komagome Hospital
Tokyo, Japan