Clinical trial: Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV With Hemophilia. (NCT04688034)

Eligibility criteria:
Inclusion Criteria:

        1. Hemophilia patients with liver cirrhosis caused by HIV/HCV co-infection that fall under
        the following 1) and 2).

          1. 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).

          2. HCV-RNA positive in serum or HCV antibody positive patients (regardless of the amount
             of viral and treatment).

        2. Patients with Child-Pugh class A or B.

        3. Patients who meet at least one of 1) to 3) for diagnosis of liver cirrhosis.

          1. FIB-4 index value is 3.25 or higher.

          2. Liver hardness value by FibroScan is 11.8 kPa or more.

          3. Abdominal CT scan shows changes in liver shape and/or portal hypertension symptoms.

        4. Patients who meet any of 1) to 3) for anti-HCV therapy.

          1. 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).

          2. Patients who have difficulty in performing DAA therapy.

          3. Patients who have passed 24 weeks or more after achieving SVR* with DAA therapy or IFN
             therapy.

        5. Patients with Performance Status 0-2.

        6. Male patients aged 20 to under 75 at the time of obtaining written consent.

        7. Patients who provided voluntary written consent to participate in this clinical trial.

        Exclusion Criteria:

          1. Patients who have cirrhosis due to causes other than HCV, and patients whose cause of
             cirrhosis is unknown.

          2. Patients with esophagogastric varices who are judged to require treatment by endoscopy
             at the time of screening.

          3. 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.).

          4. 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.

          5. Patients with active AIDS index disease requiring treatment.

          6. Patients for whom HBV, HTLV-1 active viral infection or syphilis infection cannot be
             ruled out.

          7. Serum creatinine level: Patients over 1.5 times the upper limit of the facility
             reference value.

          8. Patients with complications with uncontrolled diabetes, hypertension or heart failure.

          9. Patients with psychiatric disorders that may affect the conduct of clinical trial.

         10. Patients with or have a history of serious allergies to contrast agent.

         11. 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

         12. Patients whose dosage and administration have been changed within 12 weeks prior to
             registration if the following treatments have been given.

               -  Liver cirrhosis

               -  HIV

         13. 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.

         14. 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.

         15. Patients who have undergone liver transplantation or other organ transplantation
             (including bone marrow transplantation) and patients who have difficulty in
             intravenous administration.

         16. Male patients who do not consent to contraception from the time of consent acquisition
             to 12 weeks after the end of study drug administration.

         17. In addition, patients who are judged by the investigator or sub-investigator to be
             ineligible for this study.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 74 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction