JPRN-jRCT2031200266已完成1 期
Phase I clinical trial of CBP/Beta-catenin inhibitor OP-724 in liver cirrhosis patients caused by HIV/HCV co-infection with hemophilia. - OP-724-H101
Kimura Kiminori0 个研究点目标入组 6 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 75age old（—）
- 性别
- Male
入选标准
- •(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
- •(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.
- •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.
- •* SVR shall be as SVR12 (persistent virus negative at 12 weeks after the end of
- •administration).
- •(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.
排除标准
- •(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 complications or with previous history of primary liver cancer
- •(excluding patients who have been ablated for liver cancer for more than 1 year after
- •hepatoma removing operation or radiofrequency ablation etc.).
- •(4) Patients with complications 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
- •(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
- •(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 used investigational drugs or investigational medical
- •(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.
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