?Effect of imatinib in advance liver fibrosis patients
- Conditions
- liver fibrosis grade3-4.Fibrosis and cirrhosis of liver
- Registration Number
- IRCT20200809048342N1
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Males or females between 18-75 years old with a clinically confirmed diagnosis of Fibrosis with grade 3-4 by Metavir score.
BMI >25
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method