A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia

NCT07681089 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: OP-724-H202jRCT2031260207
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 3

Brief Summary

This is a phase 2 study to evaluate the efficacy and safety of foscenvivint in patients with liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; Hemophilia; HIV/HCV co-infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Foscenvivint

EXPERIMENTAL

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

Drug: Foscenvivint

Interventions

Foscenvivint DRUG

Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks

Also known as: CBP-beta-catenin inhibitor, OP-724, PRI-724 (former name)

Foscenvivint

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
• Patients who are serum HIV-RNA positive or HIV antibody positive, with HIV-RNA maintained at \<200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL at screening.
• Patients with HCV infection who have achieved sustained virologic response (SVR) at least 12 months before registration.
• Patients with Child-Pugh class A or B liver cirrhosis (Child-Pugh score 5-9).
• Patients who meet at least one of the following criteria for the diagnosis of liver cirrhosis:
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• Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
• Abdominal CT showing changes in liver morphology and/or findings suggestive of portal hypertension.
• Patients with an Eastern Cooperative Oncology Group Performance Status of 0-2.

You may not qualify if:

• Patients with liver cirrhosis caused by etiologies other than HCV or of unknown etiology.
• Patients with esophageal or gastric varices judged by endoscopic examination at screening to require treatment.
• Patients with current malignancy or a history of malignancy within 3 years before registration.
• Patients who have undergone liver transplantation or other organ transplantation, including bone marrow transplantation.
• Patients with active AIDS-defining disease requiring treatment. -

Sponsors & Collaborators

• Kiminori Kimura, MD: lead
• Japan Agency for Medical Research and Development: collaborator
• Ohara Pharmaceutical Co., Ltd.: collaborator

Study Sites (3)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

National Hospital Organization Osaka National Hospital

Osaka, Osaka, 540-0006, Japan

Location

Tokyo Metropolitan Komagome Hospital

Bunkyo-Ku, Tokyo, 113-8677, Japan

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hemophilia A

Interventions

ICG 001

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kiminori Kimura, MD

  Tokyo Metropolitan Komagome Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiminori Kimura, MD

CONTACT

+81-3-3823-2101; kiminori_kimura@tmhp.jp

Akemi Ikoma

CONTACT

+81-3-3823-2101; akemi_ikoma@tmhp.jp

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head, Department of Hepatology

Model Details: Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-06

Locations

JP (3)