Clinical Trials Logo
  1. Home
  2. Liver Cirrhosis
  3. NCT04688034

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

Liver Cirrhosis Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04688034
Study type Interventional
Source Komagome Hospital
Contact
Status Completed
Phase Phase 1
Start date March 15, 2021
Completion date December 31, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04533932 - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting NCT06031740 - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids N/A
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT06076330 - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension N/A
Enrolling by invitation NCT05055713 - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Not yet recruiting NCT02710227 - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis N/A
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting NCT02551250 - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Terminated NCT02311985 - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial N/A
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01618890 - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding Phase 3
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2