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

Study Identifier:
OP-724-H202
ClinicalTrials.gov Identifier:
NCT07681089
EudraCT Identifier:
N/A
Will Be Recruiting

Study Details

Medical Condition
  • Hemophilia
Study Drug
  • Drug: Foscenvivint
Date
Sep 2026 - Nov 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Male
Age: 18 - 79 Years years
Requirements Information
Inclusion and Exclusion 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:
  • 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. -

Protocol Summary

This study is looking at how safe it is to switch from emicizumab to Mim8, in people with haemophilia A. Mim8 is a new medicine that is used to prevent bleeding episodes in people with haemophilia A. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected under the skin using a pen-injector either once every week, once every two weeks or once every month. The participants will be trained in using the pen injector. The participants can choose themselves, in collaboration with the study doctor how often they get Mim8 in this study. When the participant will get their first Mim8 injection depends on their current treatment with emicizumab. The participants will get their first Mim8 injection at Visit 2. Participants will have between 6 and 27 Mim8 injections. The total number of injections participants will have depends on their dosing frequency. The study will last for about 6-12 months. While taking part in this study, there are some restrictions about what medicine participant can use. The study doctor will tell the participants more about this. In case the participants experience bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor. Female participants cannot take part if they are pregnant, breast-feeding or plan to get pregnant during the study period.

Trial Locations

Location
Status
Location
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Status
N/A
Location
National Hospital Organization Osaka National Hospital
Osaka, Osaka, Japan, 540-0006
Status
N/A
Location
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8677
Status
N/A