Effect of Imatinib in Advance Liver Fibrosis Patients

NCT05224128 | Unknown Phase 1 DMC

• 1 other identifier: 1112
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

When a recurrent, long-term injury and inflammation of the liver causes an excessive accumulation of damaged tissue, a dangerous condition called liver fibrosis develops. Most chronic liver diseases eventually lead to fibrosis. Activated hepatic stellate cells (aHSC) play an important role in the development of hepatic fibrosis. Inhibiting the proliferation of stellate cells and preventing their differentiation and activation is an ideal strategy for ameliorating hepatic fibrosis. Hence imatinib have been prescribed as a promising drug to limit the progression of liver fibrosis as a clinical inhibitor of tyrosine kinase which can affect the two main pathways leading to hepatic stellate cells activation.

Conditions

Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• Assessment of liver fibrosis score changes from baseline to 6 months

  by the FibroScan system

  6 months

Secondary Outcomes (11)

• Alanine aminotransferase serum levels changes in baseline, 3 months and 6months

  every 3 months for 6 months

• Aspartate aminotransferase serum levels changes in baseline, 3 months and 6months

  every 3 months for 6 months

• Albumin levels changes in baseline, 3 months and 6months

  every 3 months for 6 months

• Bilirubin levels changes in baseline, 3 months and 6months

  every 3 months for 6 months

• Detecting changes of Tumor necrosis factor (TNF)-alpha from baseline to 6 months

  6 months

Study Arms (2)

Imatinib Drug

EXPERIMENTAL

Standard medication of liver fibrosis + Imatinib 200 mg 1 time a day.

Drug: Imatinib 200mg

Placebo

PLACEBO COMPARATOR

Standard medication of liver fibrosis + placebo as a control group.

Drug: Placebo

Interventions

Imatinib 200mg DRUG

Imatinib have to be taken 200mg/day orally for 24 weeks in a seated position with a meal or a large (at least 250 mL) glass of water

Also known as: Trade name Gleevec or other name STI-571

Imatinib Drug

Placebo DRUG

Capsules (similar appearance with imatinib) without active substance have to be taken orally for 24 weeks in a seated position with a meal or a large (at least 250 mL) glass of water

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females between18-75 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.

You may not qualify if:

• 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 visit.
• Active, 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.
• 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 in 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.

Sponsors & Collaborators

• Research Institute for Gastroenterology and Liver Diseases (RIGLD): lead

Study Sites (1)

Research Institute of Gastroenterology & Liver Diseases

Tehran, 1985714711, Iran

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: February 4, 2022
• Study Start: February 20, 2021
• Primary Completion: February 2, 2022
• Study Completion: September 2, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-01

Locations

IR (1)