liver fibrosis grade3-4. Fibrosis and cirrhosis of liver
Conditions
Interventions
Intervention 1: Intervention group: patients will be given imatinib orally daily for 24 weeks. The dose will be 200mg/day. Sold under the brand names Gleevec. Its chemical formula is C29H31N7O.The imp
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of liver fibrosis score by the FibroScan system;. Timepoint: Before starting the administration, and at the end of the trial. Method of measurement: FibroScan system.;Detecting serological changes of: alanine aminotransferase serum levels aspartate aminotransferase serum levels Alkaline phosphatase albumin Bilirubin. Timepoint: Before starting the administration, after 3 months and at the end of the trial. Method of measurement: Serology testing.;Blood sugar and fasting insulin test. Timepoint: Before starting the administration, after 3 months and at the end of the trial. Method of measurement: Blood test.;Complete blood count. Timepoint: Before starting the administration, after 3 months and at the end of the trial. Method of measurement: Blood test.;International normalized ratio and prothrombin time. Timepoint: Before starting the administration, after 3 months and at the end of the trial. Method of measurement: Blood test.;Detecting changes of the serum inflammation markers: Tumor necrosis factor (TNF)-alpha, Interleukin-6. Timepoint: Before starting the administration and at the end of the trial. Method of measurement: Serology testing. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactBehzad Hatami
Shahid Beheshti University of Medical Sciences
Outcome results
None listed