JPRN-jRCT2080223460终止2 期
A Clinical Phase 2 Study of E6011 in Japanese Subjects with Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic Acid
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
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 <= 74age old（—）
- 性别
- All
入选标准
- •Main inclusion criteria
- •1. Diagnosed with primary biliary cholangitis corresponding to one of the following criteria
- •- Histologically confirmed chronic non-suppurative destructive cholangitis (CNSDC) with laboratory findings compatible with PBC
- •- Positivity for antimitochondrial antibodies (AMAs) with histological findings compatible with PBC but in the absence of characteristic histological findings of CNSDC
- •- No histological findings available, but positivity for AMAs as well as clinical findings and a course indicative of typical cholestatic PBC
- •2. Taking stable dose of ursodeoxycholic acid for at least 6 months (>= 600mg/day ) prior to Screening
- •3. Screening and Week 0 ALP values between 1.67 and 10 times upper limit normal
- •4. Outpatient
- •5. Has voluntarily consented, in writing, to participate in this study, and is able to comply with all aspects of the protocol
排除标准
- •Main exclusion criteria
- •1. Received following drugs within 12 weeks before starting the study treatment
- •- Drugs which suppose the efficacy to PBC: azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, penicillamine, fibrates and other systemic corticosteroids
- •- Potentially hepatotoxic drugs: methyl-dopa, sodium valproic acid and isoniazide
- •2. History or current condition of hepatic decompensation with variceal bleeds, encephalopathy >= grade 2 and poorly controlled ascites, and history of liver transplantation
- •3. History or current condition of other concomitant liver diseases including hepatitis due to HBV/HCV infection, primary sclerosing cholangitis, alcoholic liver disease (including liver cirrhosis), autoimmune liver disease requiring the treatment of systemic corticosteroids or biopsy proven NASH.
- •4. History or current clinical condition of malignant tumor, lymphoma, leukemia, or lymphoproliferative disease, except for skin carcinoma (epithelial carcinoma or basal cell carcinoma) and cervix carcinoma which has completely excised and without metastasis or recurrence for more than 5 years before informed consent
- •5. Immunodeficiency or history of human immunodeficiency virus (HIV) infection
- •6. Infection requiring hospitalization or intravenous administration of antibiotics or disease requiring administration of antivirus drugs (e.g., herpes zoster) within 4 weeks before starting the study treatment
- •7. History of tuberculosis or current complication of active tuberculosis
- •8. Positive in tuberculosis test ( T-SPOT TB Test or QuantiFERON.TB Gold Test) at Screening
- •9. History of clinically important vasculitis
- •10. History of severe allergy (shock or anaphylactoid symptoms)
- •11. Complication of uncontrolled disorders such as acute cardiac infarction, unstable angina, brain infarct, or symptomatic intracerebral hemorrhage
- •12. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, or renal disease) that could affect the participant's safety or interfere with the study assessments in the opinion of the investigator or subinvestigator
- •13. Tested positive for any of the following at Screening: HIV, HBs antigen, HBs antibody, HBc antibody, HBV DNA, HCV antibody, HTLV-1 antibody, or syphilis
- •14. Demonstrated prolonged QTcF interval (>450 ms) in repeated electrocardiogram examinations
- •15. Received immunoglobulin preparations or blood products within 24 weeks before starting the study treatment
- •16. Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive
- •17. Females who are, or may be pregnant, who are breastfeeding, who wish to become pregnant during the study period, and females or their partners who do not wish to use reliable contraceptive measures
- •18. Scheduled for surgery before Week 64
- •19. Has been treated with investigational drugs in other E6011 study
- •20. Currently enrolled in another clinical study, including the follow-up
- •21. Used any investigational drug within 28 days (or 5x the half-life, whichever is longer) prior to Screening
- •22. Judged to be ineligible to participate in this study by the investigator or sub-investigator
研究者
相似试验
未知
1 期
A phase 1, single-dose study of E6011 in Japanese healthy adult subjectsJPRN-jRCT2080221973Eisai Co., Ltd.64
未知
1 期
A phase 1/2 study of E6005 in Japanese patients with atopic dermatitisAtopic dermatitsJPRN-jRCT2080221229Eisai Co., Ltd.40
未知
1 期
A Phase 1 Single Dose Study of E6130 in Japanese Healthy Adult Male SubjectsJPRN-jRCT2080223305EA Pharma Co.,Ltd.68
终止
2 期
Study of E6011 in Japanese Subjects With Primary Biliary Cholangitis Inadequately Responding to Ursodeoxycholic AcidPrimary Biliary CholangitisNCT03092765EA Pharma Co., Ltd.29
未知
1 期
A Phase 1 Study of LY2606368 in Japanese Patients with Advanced Solid TumorseoplasmJPRN-jRCT2080222962Eli Lilly Japan K.K.