NCT06144086CompletedPhase 2
A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia (OP-724-H201)
A Multi-center, Single-arm, Open-label Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 5 (actual)
- First submitted
- 16 Nov 2023
- Start date
- 8 May 2024
- Primary completion date
- 27 Mar 2025
- Lead sponsor
- Kiminori Kimura, MD
- Diseases
- Haemophilia, HIV
- NCT number
- NCT06144086
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 5
- From 8 May 2024 to the primary completion date, 27 Mar 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
Other illness
- Patients with liver cirrhosis of which cause is not HCV or unknown.
- Patients with complication or history of malignant tumor (within 3 years before registration).
- Patients with active AIDS-indicator disease that require treatment.
Other
- Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 74 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tokyo Metropolitan Komagome Hospital Coordinator of this site? Confirm its status | Bunkyo Ku | Japan | Unknown status |
| National Hospital Organization Osaka National Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.