A Phase 2 Study of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection With Hemophilia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Foscenvivint.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: 18 years — 79 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug Foscenvivint
Experimental:Foscenvivint Administered by intravenous (IV) infusion over 3-4 hours Arm Description:Foscenvivint 280 mg/m2, once a week for 24 weeks
Primary outcome measures
- ALBI score [Time frame: Baseline to 24 weeks after administration]
Eligibility criteria
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:
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- 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. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 3 centers
- Hokkaido University Hospital — Sapporo
- National Hospital Organization Osaka National Hospital — Osaka
- Tokyo Metropolitan Komagome Hospital — Bunkyo-Ku
Identifiers
NCT: NCT07681089 · OP-724-H202 · jRCT2031260207