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

NCT ID: NCT06144086

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2026-03-31

Brief Summary

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.

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Foscenvivint

Foscenvivint 280 mg/m2, twice a week for 24 weeks

Group Type: EXPERIMENTAL

Foscenvivint

Intervention Type: DRUG

Administered by intravenous (IV) infusion over 3-4 hours

Interventions

Foscenvivint

Administered by intravenous (IV) infusion over 3-4 hours

Intervention Type: DRUG

Other Intervention Names

CBP-beta-catenin inhibitor; OP-724; PRI-724 (former name)

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Japan Agency for Medical Research and Development

OTHER_GOV

Sponsor Role: collaborator

Kiminori Kimura, MD

OTHER

Sponsor Role: lead

Responsible Party

Kiminori Kimura, MD

Director, Department of Hepatology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kiminori Kimura, MD

Role: PRINCIPAL_INVESTIGATOR

Tokyo Metropolitan Komagome Hospital

Locations

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

National Hospital Organization Osaka National Hospital

Osaka, Osaka, Japan

Tokyo Metropolitan Komagome Hospital

Bunkyo-Ku, Tokyo, Japan

Countries

Japan

Other Identifiers

jRCT2031230461

Identifier Type: OTHER

Identifier Source: secondary_id

OP-724-H201

Identifier Type: -

Identifier Source: org_study_id