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

RecruitingPhase 2

Sponsor: Kiminori Kimura, MD

Conditions: Liver Cirrhosis

Interventions: Foscenvivint

Countries: Japan

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 overview

Sex: MALE

Age: 18 Years to 79 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 \<200 copies/mL and a CD4-positive T lymphocyte count of ≥200 cells/µL 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:

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  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. -

Locations (3)

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