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

RecruitingPhase 2Ages 18 Years - 79 YearsMaleKiminori Kimura, MD
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ200 cells/ยตL 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 โ‰ฅ12.5 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. -
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What it tests

  • Foscenvivint
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Where

4 sites
Hokkaido University Hospital
Sapporo, Japan
National Hospital Organization Sendai Medical Center
Sendai, Japan
National Hospital Organization Osaka National Hospital
Osaka, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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