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IRCT20200809048342N1 IRCT 2020-08-25 Shahid Beheshti University of Medical Sciences ٍEffect of imatinib in advance liver fibrosis patients A Phase I/II, Randomized, Double-Blind Intervention Trial for Evaluating the Safety and Efficacy of Imatinib in Subjects with Advance fibrosis 2020-09-05 anticipated 60 Complete https://irct.ir/trial/50254 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization with block size 4.Participants were assigned to two groups of Imatinib drug and placebo using block randomization method (quadruple blocks with equal volume). This ensures balance in the number of groups. In this study, due to the existence of two treatment groups, for 4 blocks, there will be six different manners as follows: ( Control group=C and Treatment group=T) 1. TTCC 2. TCTC 3. TCCT 4. CCTT 5. CTCT 6. CTTC Randomized selection will be carried out each time by Random allocation software, Blinding description: - All participants (patients) will be inform about research project. - All patients and medical doctors are blind about receiving placebo or imatinib. - Academic researchers are aware about receiving treatments for all patients. - The blind approach would be accomplished by giving the doctor unknown sealed drug or placebo, hence, both the physician and the patients are blind in terms of medication and placebo. 1-2 liver fibrosis grade3-4. 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 importer company of the drug used in this clinical trial is Sobhan Oncology Pharmaceutical Company and its manufacturer is CIPLA Company in India. Intervention 2: Control group: patients will be given placebo orally daily for 24 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Behzad Hatami
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak, Tehran, Iran
Tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2516 bzd_hatami@yahoo.com Shahid Beheshti University of Medical Sciences scientific Kaveh Baghaei
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
Tehran Iran (Islamic Republic of) 1985714711 +98 21 2243 2516 kavehbaghaei@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 75 years Both 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. K74 Fibrosis and cirrhosis of liver Treatment - Drugs Placebo 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 importer company of the drug used in this clinical trial is Sobhan Oncology Pharmaceutical Company and its manufacturer is CIPLA Company in India. Control group: patients will be given placebo orally daily for 24 weeks. 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. Shahid Beheshti University of Medical Sciences Approved 2020-07-18 Ethics committee of shahid beheshti university of medical science Research Institute for Gastroenterology and Liver Diseases, taleghani hospital, Arabi st., Velenjak ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)