Status:
COMPLETED
Safety and Tolerability Study of OP-724 in Liver Cirrhosis Patients by HIV/HCV with Hemophilia.
Lead Sponsor:
Kiminori Kimura, MD
Collaborating Sponsors:
Japan Agency for Medical Research and Development
Ohara Pharmaceutical Co., Ltd.
Conditions:
Liver Cirrhosis
Eligibility:
MALE
20-74 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia.
Detailed Description
This trial is an uncontrolled, open-label, single-center phase I study in liver cirrhosis patients caused by human immunodeficiency virus (HIV)/hepatitis C virus (HCV) co-infection with hemophilia. L...
Eligibility Criteria
Inclusion
- 1\. 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).
- 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.
- 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.
- 4\. 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.
- 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
- 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.
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04688034
Start Date
March 15 2021
End Date
July 5 2022
Last Update
October 21 2024
Active Locations (1)
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1
Tokyo Metropolitan Komagome Hospital
Bunkyo-Ku, Tokyo, Japan, 113-8677