Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia.
Study Details
- Hemophilia
- Drug: OP-724
- Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under the following 1) and 2).
- HIV-RNA positive in serum or HIV antibody positive patients (the amount of HIV-RNA in the blood at the time of screening is less than 200 copies/mL, and the number of CD4 positive T lymphocytes can be maintained at 200/micro L or more).
- HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount of viral and treatment).
- Patients with Child-Pugh class A or B.
- Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.
- FIB-4 index value is 3.25 or higher.
- Liver hardness value by FibroScan is 11.8 kPa or more.
- Abdominal CT scan shows changes in liver shape and/or portal hypertension symptoms.
- Patients who meet any of 1) to 3) for anti-HCV therapy.
- Patients who have not reached the sustained virological response (SVR) * with the direct acting antivirals (DAA) therapy. * SVR shall be as SVR12 (persistent virus negative at 12 weeks after the end of administration).
- Patients who have difficulty in performing DAA therapy.
- Patients who have passed 24 weeks or more after achieving SVR* with DAA therapy or IFN therapy.
- Patients with Performance Status 0-2.
- Male patients aged 20 to under 75 at the time of obtaining written consent.
- Patients who provided voluntary written consent to participate in this clinical trial.
- Patients who have cirrhosis due to causes other than HCV, and patients whose cause of cirrhosis is unknown.
- Patients with esophagogastric varices who are judged to require treatment by endoscopy at the time of screening.
- Patients with complication or with previous history of primary liver cancer (excluding patients who have been for more than 1 year after hepatoma removing operation or radiofrequency ablation etc.).
- Patients with complication or with previous history of malignant tumor (within 3 years before screening).However, except for the following diseases: treated basal cell carcinoma, treated lung carcinoma in situ, or well-controlled superficial (non-invasive) bladder cancer.
- Patients with active AIDS index disease requiring treatment.
- Patients for whom HBV, HTLV-1 active viral infection or syphilis infection cannot be ruled out.
- Serum creatinine level: Patients over 1.5 times the upper limit of the facility reference value.
- Patients with complications with uncontrolled diabetes, hypertension or heart failure.
- Patients with psychiatric disorders that may affect the conduct of clinical trial.
- Patients with or have a history of serious allergies to contrast agent.
- Patients who have not passed the following period at the time of registration and after the end of anti-HCV therapy.
- IFN preparation 12 weeks after the last administration
- Ribavirin preparation 16 weeks after the last administration
- 16 weeks after the last administration of DAA
- Patients whose dosage and administration have been changed within 12 weeks prior to registration if the following treatments have been given.
- Liver cirrhosis
- HIV
- Patients with a history of drug or alcohol intoxication within 5 years prior to obtaining written consent, or patients with a history of drug or alcohol abuse within the last 1 year.
- Patients who participated in other clinical trials within 30 days before obtaining written consent and used or had used investigational drugs or investigational medical devices.
- Patients who have undergone liver transplantation or other organ transplantation (including bone marrow transplantation) and patients who have difficulty in intravenous administration.
- Male patients who do not consent to contraception from the time of consent acquisition to 12 weeks after the end of study drug administration.
- In addition, patients who are judged by the investigator or sub-investigator to be ineligible for this study.
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.