EUCTR2014-003942-28-PL进行中（未招募）1 期
Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 258
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
- •2. The subject or, when applicable, the subject’s legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •3. The subject has chronic cholestatic liver disease, of at least 6 months duration, with a subsequent diagnosis of PSC, based on cholangiographic findings of intrahepatic and/or extrahepatic bile duct irregularities consistent with PSC.
- •4. The subject has a diagnosis of IBD (either UC, CD, or IBDU), established at least 3 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
- •5. The subject is male or female and aged 18 years and older, inclusive.
- •6. A male subject who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of the informed consent throughout the duration of the study and for 18 weeks after last dose.
- •7. A female subject of childbearing potential* who is sexually active with a non-sterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 18 weeks after the last dose.
- •8. The subject has had a colorectal cancer screen within 12 months of the Screening Visit with no signs of malignancy, dysplasia, or neoplasia.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 246
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •1. The subject has had previous exposure to vedolizumab
- •2. The subject has a history of hypersensitivity or allergies to vedolizumab
- •3. The subject has had previous exposure to natalizumab, efalizumab, rituximab or any other integrin antagonist
- •4. The subject has received any investigational or approved biologic or biosimilar agent
- •5. The subject has received any of the following for the treatment of underlying disease within 30 days of screening:
- •Nonbiologic therapies other than those specifically listed in the protocol Section 7.3.1 Permitted Medications for the Treatment of IBD
- •An approved nonbiologic therapy in an investigational protocol
- •6. The subject has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes
- •7. The subject has any history of malignancy, except for (a) adequately treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has not recurred for at least 1 year prior to randomization; and (c) history of cervical carcinoma in situ that has not recurred for at least 3 years prior to randomization
- •8. The subject has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, demylelinating or neurodegenerative disease
- •9. The subject has a positive response on the PML subjective symptom checklist prior to the administration of study drug
研究者
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