Liver Cirrhosis
Conditions
Keywords
Liver Cirrhosis, Hemophilia, HIV/HCV co-infection
Brief 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.
Detailed description
This is a multicenter, single-arm, open-label phase 2 study of foscenvivint administered intravenously once-weekly for 24 weeks. A follow-up visit will be conducted 4 weeks after the final administration. Eligible patients are those with Child-Pugh class A or B liver cirrhosis resulting from HIV/HCV co-infection in the setting of hemophilia.
Interventions
DRUGFoscenvivint
Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
Sponsors
Kiminori Kimura, MD
Japan Agency for Medical Research and Development
Ohara Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
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: <!-- --> 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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ALBI score | Baseline to 24 weeks after administration | Change from baseline in ALBI score at 24 weeks after administration. ALBI score = (log10 bilirubin \[mg/dL\] x 17.1) x 0.66 + (albumin \[g/dL\] x 10 x -0.085) |
Countries
Japan
Contacts
CONTACTKiminori Kimura, MD
CONTACTAkemi Ikoma
PRINCIPAL_INVESTIGATORKiminori Kimura, MD
Tokyo Metropolitan Komagome Hospital
Outcome results
None listed