Status:
ACTIVE_NOT_RECRUITING
A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)
Lead Sponsor:
Kiminori Kimura, MD
Collaborating Sponsors:
Japan Agency for Medical Research and Development
Conditions:
Liver Cirrhosis
Eligibility:
MALE
18-74 years
Phase:
PHASE2
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 administr...
Eligibility Criteria
Inclusion
- Key Inclusion Criteria
- Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
- 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).
- 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:
- Liver stiffness measurement by FibroScan is \>= 12.5 kPa (Fibrosis stage F4) at screening.
- 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.
Exclusion
Key Trial Info
Start Date :
May 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06144086
Start Date
May 8 2024
End Date
March 31 2026
Last Update
March 17 2025
Active Locations (3)
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1
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
2
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan, 540-0006
3
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8677