NCT04688034

Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia.

Phase I Clinical Trial of CBP/Beta-catenin Inhibitor OP-724 in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia. (OP-724-H101)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Kiminori Kimura, MD · Academic / Other
• Sex: Male
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

Detailed description

This trial is an uncontrolled, open-label, single-center phase I study in liver cirrhosis patients caused by human immunodeficiency virus (HIV)/hepatitis C virus (HCV) co-infection with hemophilia. Liver cirrhosis patients due to co-infection of HIV and HCV with hemophilia who have a Child-Pugh classification of A or B are included. OP-724 is intravenously administered twice a week (4 hours) for 12 weeks as an administration schedule. At 14 days before the administration of the first cycle, the dose planned for the first cycle will be administered once by continuous intravenous administration for 4 hours, and the safety and pharmacokinetics will be evaluated from the day of administration to the day after the administration. If an integrase inhibitor is used in combination as a key drug for antiretroviral drugs, its pharmacokinetics will be evaluated at the same time. A dose escalation study with 2 doses (cohort 1: 140 mg/m2/4hr (starting dose), cohort 2: 280 mg/m2/4hr) will be conducted, and 3 patients in each cohort will be enrolled. Comprehensively investigate the safety and pharmacokinetic data after OP-724 administration, and evaluate the safety and tolerability of OP-724 administration.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DRUG	OP-724	Twice a week for 4 hours continuous intravenous administration of OP-724.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-07-05
• Completion: 2022-07-05
• First posted: 2020-12-29
• Last updated: 2024-10-21

Locations

1 site across 1 country: Japan