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NCT07681089
A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
Conditions: Liver Cirrhosis
Sex: Male
Ages: 18 Years – 79 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 7
Sponsor: Kiminori Kimura, MD
Location: Hokkaido University Hospital Sapporo Hokkaido
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 Criteria
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 \
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. -
Source: ClinicalTrials.gov (NCT07681089). StuddyBuddy aggregates publicly available trial information.