EUCTR2020-003990-23-IT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 FOLLOWING STEROID TAPERING IN PATIENTS WITH AUTOIMMUNE HEPATITIS -
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
- •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
- •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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