Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia. (NCT04688034) | Clinical Trial Compass
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.
Who can participate
Age range
20 Years – 74 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. Patients who have cirrhosis due to causes other than HCV, and patients whose cause of cirrhosis is unknown.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serious Adverse Events (Side Effects)
Timeframe: 28 days after the last administration of OP-724.
. 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.