A Phase 2 Trial of Foscenvivint in Liver Cirrhosis Patients Caused by HIV/HCV Co-infection with Hemophilia (OP-724-H201)
Study Details
- Hemophilia
- Drug: Foscenvivint
- Key Inclusion Criteria
- Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2):
- Serum HIV-RNA positive or HIV antibody positive patients (maintaining HIV-RNA \< 200 copies/mL and CD4 positive T lymphocyte count \>= 200 cells/µL at screening).
- Regarding HCV, patients who had passed \>= 12 months after achieving SVR at registration.
- Patients with Child-Pugh classification A or B (Child-Pugh score 5-9).
- Patients who meet at least one of 1) to 2) for diagnosis of liver cirrhosis:
- Liver stiffness measurement by FibroScan is \>= 12.5 kPa (Fibrosis stage F4) at screening.
- Abdominal CT scan shows changes in liver shape and/or portal hypertension.
- Patients with Performance Status 0-2.
- Key Exclusion Criteria
- Patients with liver cirrhosis of which cause is not HCV or unknown.
- Patients with esophageal gastric varices judged to require treatment by endoscopic examinations at screening.
- Patients with complication or history of malignant tumor (within 3 years before registration).
- Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation).
- Patients with active AIDS-indicator disease that require 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.