Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 34
Summary
- Conditions
- Hepatitis B
- Hepatitis C
- Liver Cirrhoses
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 74 years
- Gender
- Both males and females
Description
?Phase I Phase? To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724. ?Phase IIa phase? To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV...
?Phase I Phase? To evaluate safety and pharmacokinetics when PRI-724 is administered to patients with HCV or HBV liver cirrhosis , and determine the recommended dose of PRI-724. ?Phase IIa phase? To evaluate the efficacy and safety of the recommended dose of PRI-724 administered to patients with HCV or HBV liver cirrhosis.
Tracking Information
- NCT #
- NCT03620474
- Collaborators
- PRISM BioLab Co.,Ltd.
- Kyushu University
- National Center for Global Health and Medicine, Japan
- Japan Agency for Medical Research and Development
- Ohara Pharmaceutical Co., Ltd.
- Investigators
- Principal Investigator: Kiminori Kimura, MD Komagome Hospital
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