IRCT20200809048342N1招募中1 期
A Phase I/II, Randomized, Double-Blind Intervention Trial for Evaluating the Safety and Efficacy of Imatinib in Subjects with Advance fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
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
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Males or females between 18-75 years old with a clinically confirmed diagnosis of Fibrosis with grade 3-4 by Metavir score.
- •Negative alcohol screen.
- •Able to understand and willing to voluntarily sign an informed consent form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) authorization.
排除标准
- •Known cardiovascular disease.
- •Requiring any of the following medications during the duration of the study:History of cirrhosis based on imaging or clinical criteria and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding.History of hepatocellular carcinoma (HCC)History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous carcinoma at the time of Screening visitActive, serious infections that requires parenteral antibiotic or antifungal therapy within 30 days prior to Screening visit.
- •Females who are pregnant or breastfeeding.
- •Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons).
- •Use of any experimental medications within the last 6 months of Screening Visit.
- •Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements.
- •Familial dyslipidemia
- •Weight loss of >5% within 6 months prior to Screening, based on subject's reporting
- •Currently or participated in a weight loss program within the last 6 months
- •Any history of bariatric surgery
- •Diabetes mellitus Type I
- •Daily alcohol intake >20 ml (2 units)/day for women and 30 ml (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire at Screening and plan to consume the same alcohol amount referenced above during the trial
- •Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids >10 mg prednisone-equivalent concurrently or within 1 year prior to Screening
- •Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator.
- •History or presence of hepatitis B or C or human immunodeficiency virus (HIV)
- •Uncontrolled arterial hypertension
- •Any severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the subject inappropriate for entry into this study.
- •Subjects who have previously received imatinib or who have history of hypersensitivity, allergy, intolerance or contraindication to imatinib.
研究者
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