A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia (OP-724-H201)

A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia

This is a phase 2 trial of foscenvivint in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia to evaluate the efficacy, safety and pharmacokinetics.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Foscenvivint

Detailed Description

This is designed a multi-center, single-arm, open-label trial of foscenvivint administered intravenously twice a week for 24 weeks. A follow up visit will be conducted 4 weeks after the last administration.

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Osaka
    • Osaka, Osaka, Japan, 540-0006
      • National Hospital Organization Osaka National Hospital
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria

• Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):

  1. Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA < 200 copies/mL and CD4 positive T lymphocyte count >= 200 cells/µL at screening).
  2. Regarding HCV, patients who had passed >= 12 months after achieving SVR at registration.
• Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).

• Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:

  1. Liver stiffness measurement by FibroScan is >= 12.5 kPa (Fibrosis stage F4) at screening.
  2. Abdominal CT scan shows changes in liver shape and/or portal hypertension.
• Patients with Performance Status 0-2.

Key Exclusion Criteria

• Patients with liver cirrhosis of which cause is not HCV or unknown.
• Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
• Patients with complication or history of malignant tumor (within 3 years before registration).
• Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
• Patients with active AIDS-indicator disease that require treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Foscenvivint; Foscenvivint 280 mg/m2, twice a week for 24 weeks	Drug: Foscenvivint; Administered by intravenous (IV) infusion over 3-4 hours; Other Names: CBP-beta-catenin inhibitor; PRI-724 (former name); OP-724

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ALBI score	Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin [mg/dL] x 17.1) x 0.66 + (albumin [g/dL] x 10 x -0.085)	Baseline to 24 weeks after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child-Pugh score	Change from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration. Child-Pugh score is determined by scoring the following five clinical measures. Encephalopathy: None = 1 point, Grade 1 and 2 = 2 points, Grade 3 and 4 = 3 points Ascites: None = 1 point, slight = 2 points, moderate = 3 points Bilirubin: < 2 mg/dL = 1 point, 2 to 3 mg/dL = 2 points, > 3 mg/dL = 3 points Albumin: > 3.5 g/dL = 1 point, 2.8 to 3.5 g/dL = 2 points, < 2.8 g/dL = 3 points Prothrombin Time (%): > 70% = 1 point, 40 to 70% = 2 points, < 40% = 3 points	Baseline to 12, 24 and 28 weeks after administration
ALBI score	Change from baseline in ALBI score at 12 and 28 weeks after administration.	Baseline to 12 and 28 weeks after administration
Liver stiffness measurement by FibroScan	Change from baseline in Liver stiffness measurement by FibroScan at 12 and 24 weeks after administration.	Baseline to 12 and 24 weeks after administration
Serum fibrosis markers	Change from baseline in Serum fibrosis markers at 12 and 24 weeks after administration.	Baseline to 12 and 24 weeks after administration
Serum albumin	Change from baseline in serum albumin at 12, 24 and 28 weeks after administration.	Baseline to 12, 24 and 28 weeks after administration
Serum bilirubin	Change from baseline in serum bilirubin at 12, 24 and 28 weeks after administration.	Baseline to 12, 24 and 28 weeks after administration
PT%	Change from baseline in PT% at 12, 24 and 28 weeks after administration.	Baseline to 12, 24 and 28 weeks after administration
FIB-4 index	Change from baseline in FIB-4 index at 12, 24 and 28 weeks after administration. FIB-4 index = (Age [years] x AST [U/L]) / (Platelet Count [10*9/L] x √ ALT [U/L] )	Baseline to 12, 24 and 28 weeks after administration
mALBI grade	Percentage of subjects who achieved >= 1 stage improvement in mALBI grade from baseline at 12, 24 and 28 weeks after administration. Based on ALBI score, mALBI grade is classified into Grade 1 to 3 shown below. mALBI grade: Grade 1: <=-2.60; Grade 2a: >-2.60 to <-2.27; Grade 2b: >=-2.27 to -1.39; Grade 3: >-1.39	Baseline to 12, 24 and 28 weeks after administration
MELD score	Change from baseline in MELD score at 12, 24 and 28 weeks after administration. The Model for End-Stage Liver Disease (MELD) is a scoring system for assessing the severity of chronic liver disease and uses the subject's values for total bilirubin, serum creatinine, and the international normalized ratio (INR) for prothrombin time to predict survival. The higher the score, the more serious the subject's disease. MELD is calculated according to the following formula: MELD score = 3.78 x ln(serum bilirubin [mg/dL]) + 11.2 x ln(PT-INR) + 9.57 x ln(serum creatinine [mg/dL]) + 6.43	Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification	Percentage of subjects who changed from grade B at baseline to grade A at 12, 24 and 28 weeks after administration in Child-Pugh classification. Based on the total points in Child-Pugh score (scale range 5-15 points, the severity increases sequentially from 5 to 15 points), the severity of the disease is classified into Grade A to C shown below. Child-Pugh classification: Grade A: 5 to 6 points -> Compensated cirrhosis; Grade B: 7 to 9 points -> Decompensated cirrhosis; Grade C: 10 to 15 points -> Decompensated cirrhosis	Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh score	Percentage of subjects who achieved >= 2 points improvement from baseline in Child-Pugh score at 12, 24 and 28 weeks after administration.	Baseline to 12, 24 and 28 weeks after administration
Achievement in Child-Pugh classification and score	Percentage of subjects who changed from grade B to grade A in Child-Pugh classification and achieved >= 2 points improvement in Child-Pugh score from baseline at 12, 24 and 28 weeks after administration.	Baseline to 12, 24 and 28 weeks after administration

Collaborators and Investigators

• Sponsor: Kiminori Kimura, MD
• Collaborators: Japan Agency for Medical Research and Development
• Investigators: Principal Investigator: Kiminori Kimura, MD, Tokyo Metropolitan Komagome Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2024
• Primary Completion (Actual): March 27, 2025
• Study Completion (Actual): March 27, 2025

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 16, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Hemophilia; HIV/HCV co-infection
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Digestive System Diseases; Hematologic Diseases; Liver Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Fibrosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Hemophilia A; Liver Cirrhosis; ICG 001
• Other Study ID Numbers: OP-724-H201; jRCT2031230461 (Other Identifier: Japan Registry of Clinical Trials (jRCT))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No