EUCTR2020-003990-23-PT进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMIZED,PARALLEL-GROUP, PHASE 2 STUDY TO INVESTIGATE THE EFFECT OF RO7049665 ON THE TIME TO RELAPSE FOLLOWINGSTEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 84
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
- •¿Age between 18 to 75 years
- •Type of Participants and Disease Characteristics
- •¿Patients with a definite diagnosis of AIH (type 1, 2 and 3) as per simplified or revised original diagnostic criteria
- •¿Patients who have been in biochemical remission for > 2 years prior to randomization
- •¿Patients who have been on stable treatment for at least 6 months prior to randomization
- •¿No signs of liver inflammation on a liver biopsy taken no more than 12 months prior to randomization.
- •¿Patients with AIH who have previously not attempted to taper CCS to 0 mg/day
- •¿Body mass index within the range of 18-35 kg/m2 (inclusive)
- •Sex and Contraception/Barrier Requirements
- •¿Women of childbearing potential, who: agree to remain abstinent or use at least one acceptable contraceptive methods during the treatment period and for at least 28 days after the final dose of study drug
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 34
排除标准
- •Medical Conditions
- •¿Patients with cirrhosis (F4 fibrosis by Fibroscan®) with significant impairment of liver function (Child Pugh category B or C)
- •¿Any other autoimmune disease requiring immunomodulating treatment
- •¿History of infection with hepatitis B, human immunodeficiency virus, active hepatitis C virus (HCV) infection, detection of replicating CMV or Epstein-Barr virus (EBV)
- •¿Active infections requiring systemic therapy with antibiotic, antiviral, or antifungal treatment or febrile illness within 7 days before Day-1
- •¿History of primary or acquired immunodeficiency
- •¿Female patients: Pregnant or lactating
- •¿Symptomatic herpes zoster within 3 months prior to screening
- •¿History of active or latent tuberculosis or a positive Quantiferon Gold test
- •¿History of clinically significant severe drug allergies, multiple drug allergies, allergy to any constituent of the product, or intolerance to topical steroids
- •¿Lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years and in situ carcinoma of the cervix that was completely removed surgically. Breast cancer within the past 10 years
- •¿Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
- •¿Any condition or disease detected during the medical interview/physical examination that would render the patient unsuitable for the study, place the patient at undue risk, or interfere with the ability of the patient to complete the study in the opinion of the Investigator
- •Prior/Concomitant Therapy
- •¿CCSs of < 5 mg/day, or < 2.5 mg CCSs plus immune suppressant, or < 3 mg/day budesonide with or without immune suppressant
- •¿CCSs > 20 mg/day or > 9 mg/day budesonide
- •¿NSI daily dose higher than recommended standard of care therapy
- •¿T or B cell-depleting therapy within the last 12 months or T- or B-cell number below normal due to depleting therapy
- •Prior/Concurrent Clinical Study Experience
- •¿Leukocyte apheresis within 12 weeks of screening.
- •¿Donation of blood or blood products in excess of 500 mL within 3 months prior to screening.
- •¿Exposure to any investigational treatment within 6 months prior to Day 1
- •Laboratory Abnormalities
- •¿Abnormal hematologic, hepatic enzyme or hepatic function, biochemistry values
- •Other Exclusions
- •¿History of regular alcohol consumption within 2 months of screening
- •¿Any suspicion or history of illicit drug use
- •¿Patients under judicial supervision, guardianship, or curatorship
研究者
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