CompletedPhase 1

Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia.

Japan5 participantsStarted 2021-03-15

Plain-language summary

To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.

Age range20 Years – 74 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).
✓. 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 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 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.

Serious Adverse Events (Side Effects)

Timeframe: 28 days after the last administration of OP-724.

NCT IDNCT04688034

SponsorKiminori Kimura, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-05

Who can participate

Age range20 Years – 74 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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).
✓. 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 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 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.