A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia. (OP-724-H202)

A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV/HCV Co-infection in the Setting of Hemophilia.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Drug: Foscenvivint

Detailed Description

This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration.

Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.

• Study Type: Interventional
• Enrollment (Estimated): 4
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kiminori Kimura, MD; Phone Number: +81-3-3823-2101; Email: kiminori_kimura@tmhp.jp
• Study Contact Backup: Name: Akemi Ikoma; Phone Number: +81-3-3823-2101; Email: akemi_ikoma@tmhp.jp

Study Locations

• Japan
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
      • Contact: Tomoyuki Endo, MD; Phone Number: +81-11-716-1161; Email: t-endo@med.hokudai.ac.jp
      • Principal Investigator: Tomoyuki Endo, MD
  • Osaka
    • Osaka, Osaka, Japan, 540-0006
      • National Hospital Organization Osaka National Hospital
      • Contact: Ryotaro Sakamori, MD; Phone Number: +81-6-6942-1331; Email: sakamori@gh.med.osaka-u.ac.jp
      • Principal Investigator: Ryotaro Sakamori, MD
  • Tokyo
    • Bunkyo-Ku, Tokyo, Japan, 113-8677
      • Tokyo Metropolitan Komagome Hospital
      • Contact: Kiminori Kimura, MD; Phone Number: +81-3-3823-2101; Email: kiminori_kimura@tmhp.jp
      • Contact: Akemi Ikoma; Phone Number: +81-3-3823-2101; Email: akemi_ikoma@tmhp.jp
      • Principal Investigator: Kiminori Kimura, MD

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:

  1. 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.

  2. 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:
  1. Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.

  2. 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.

Exclusion Criteria:

• 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. -

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
Active Comparator: Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks	Drug: Foscenvivint; Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks

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

Collaborators and Investigators

• Sponsor: Kiminori Kimura, MD
• Collaborators: Japan Agency for Medical Research and Development; Ohara Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kiminori Kimura, MD, Tokyo Metropolitan Komagome Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: June 26, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 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
• Other Study ID Numbers: OP-724-H202; jRCT2031260207 (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