A Multicenter, Single-Arm, Open-Label Phase 2 Study of Once-Weekly Foscenvivint in Patients With Liver Cirrhosis Due to HIV/HCV Co-infection in the Setting of Hemophilia
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 4
- Locations
- 3
- Primary Endpoint
- ALBI score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with hemophilia and liver cirrhosis caused by HIV/HCV co-infection who meet both of the following criteria:
- •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.
- •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:
- •Liver stiffness measurement by FibroScan of ≥12.5 kPa, corresponding to fibrosis stage F4, at screening.
- •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. -
Arms & Interventions
Foscenvivint
Foscenvivint 280 mg/m2, once a week for 24 weeks
Intervention: Foscenvivint (Drug)
Experimental:Foscenvivint Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
Intervention: Foscenvivint (Drug)
Outcomes
Primary Outcomes
ALBI score
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Kiminori Kimura, MD
Head, Department of Hepatology
Komagome Hospital