drugset

drugset / Trial / NCT04688034

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

NCT04688034 ↗

Phase 1 Completed 5 enrolled Kiminori Kimura, MD Japan Agency for Medical Research and Development · collab Ohara Pharmaceutical Co., Ltd. · collab

NaSingle-groupOpen-labelTreatment

Summary

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

Timeline

Start: 2021-03-15
Primary completion: 2022-07-05
Completion: 2022-07-05

Publications

Kimura K, Tanuma J, Kimura M, Imamura J, Yanase M, Ieiri I, Kurosaki M, Watanabe T, Endo T, Yotsuyanagi H, Gatanaga H. Safety and tolerability of OP-724 in patients with haemophilia and liver cirrhosis due to HIV/HCV coinfection: an investigator-initiated, open-label, non-randomised, single-centre, phase I study. BMJ Open Gastroenterol. 2024 Apr 27;11(1):e001341. doi: 10.1136/bmjgast-2023-001341.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	OP-724	Unknown	140 mg/m2	Intravenous
Subject	OP-724	Unknown	280 mg/m2	Intravenous

Indications