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Recruiting Phase 2

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

NCT07681089 · tracked via the Priya Life Science Japan tracker
Sponsor
Kiminori Kimura, MD
Phase
Phase 2
Started
2026-10-01
Last updated
2026-10-05

Condition(s) studied

Liver Cirrhosis

Investigational drug(s) / intervention(s)

Foscenvivint

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

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
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. -

Primary outcome measure(s)

  • ALBI score — Baseline to 24 weeks after administration
    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)

Trial sites (4)

FacilityCityRegionStatus
Hokkaido University Hospital Sapporo Hokkaido Recruiting
National Hospital Organization Sendai Medical Center Sendai Miyagi Recruiting
National Hospital Organization Osaka National Hospital Osaka Osaka Recruiting
Tokyo Metropolitan Komagome Hospital Bunkyo-Ku Tokyo Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07681089 on ClinicalTrials.gov ↗ ← All trials in Japan