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

NCT06144086

CompletedPhase 2

Sponsor: Kiminori Kimura, MD

Conditions: Liver Cirrhosis

Interventions: Foscenvivint

Countries: Japan

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.

Eligibility overview

Sex: MALE

Age: 18 Years to 74 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (3)

Sapporo, Hokkaido, Japan
Osaka, Osaka, Japan
Bunkyo-Ku, Tokyo, Japan