Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

NCT05284448 | Completed Phase 3

• 1 other identifier: 312
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.

Conditions

NASH - Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• improvement in liver aminotransferases(ALT and AST)

  Difference between last and first measurements

  6 months compared to the baseline

• NAFLD fibrosis score (NFS)

  Change in NAFLD fibrosis score (NFS) (lower score means better outcome).

  6 months compared to the baseline

Secondary Outcomes (11)

• The Aspartate (AST) to Platelet Ratio Index (APRI) score:

  6 months compared to the baseline

• The Fibrosis-4 (FIB-4) values:

  6 months compared to the baseline

• Serum Alkaline Phosphatase level (ALP)

  6 months compared to the baseline

• Serum Gamma-glutamyl Transferase level (GGT)

  6 months compared to the baseline

• Serum total and direct bilirubin.

  6 months compared to the baseline

Study Arms (2)

Pentoxifylline Group

EXPERIMENTAL

25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.

Drug: pentoxifylline (Trental SR®)

Control Group

NO INTERVENTION

25 patients will receive their standard therapy only

Interventions

pentoxifylline (Trental SR®) DRUG

400 mg three times daily

Pentoxifylline Group

Eligibility Criteria

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

You may qualify if:

• Aged between 18- 60 years old.
• Both sexes
• Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
• clinical examination (obese, high body mass index).
• radiological criteria of fatty liver (abdominal ultrasonography).
• laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
• The ability to give informed consent

You may not qualify if:

• Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.
• \. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.
• \. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.
• \. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.

Cairo, Egypt

Location

Related Publications (2)

• Leoncini L, Vindigni C, Megha T, Funto I, Pacenti L, Musaro M, Renieri A, Seri M, Anagnostopoulos J, Tosi P. Epstein-Barr virus and gastric cancer: data and unanswered questions. Int J Cancer. 1993 Apr 1;53(6):898-901. doi: 10.1002/ijc.2910530605.

  PMID: 7682538 BACKGROUND

• Girolami A. Tentative and updated classification of factor X variants. Acta Haematol. 1986;75(1):58-9. doi: 10.1159/000206084. No abstract available.

  PMID: 3088890 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Zeinab Zalat, PhD

  Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University(Girls, Cairo)

  STUDY CHAIR

• Adel Gaber Bakr, PhD

  Assistant Professor of Pharmacology and Toxicology, Al-Azhar University (Boys, Assiut)

  STUDY DIRECTOR

• Ahmed ElGhandour, MD

  Assistant Professor of Internal Medicine and Gastroenterology, Faculty of Medicine, Ain-Shams University

  STUDY DIRECTOR

• ahmed abomandour, Demonstrator

  Demonstrator of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University (Boys, Assiut)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Clinical trial, parallel, randomized, prospective, controlled study

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 17, 2022
• Study Start: February 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

EG (1)