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Completed

NCT Number: NCT05284448

Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Cairo, Egypt

About this study

Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality.

Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Appropriate exclusion of other liver diseases

Exclusion criteria

1- 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

Treatment and study plan

pentoxifylline (Trental SR®)

Drug

400 mg three times daily

Primary outcomes

  1. improvement in liver aminotransferases(ALT and AST)

    Time frame: 6 months compared to the baseline

    Difference between last and first measurements

  2. NAFLD fibrosis score (NFS)

    Time frame: 6 months compared to the baseline

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

Secondary outcomes

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

    Time frame: 6 months compared to the baseline

    Change in (APRI) score (lower score means better outcome).

  2. The Fibrosis-4 (FIB-4) values:

    Time frame: 6 months compared to the baseline

    Change in (FIB-4) values (lower values means better outcome).

  3. Serum Alkaline Phosphatase level (ALP)

    Time frame: 6 months compared to the baseline

    Change in ALP serum level as inflammatory markers of NASH

  4. Serum Gamma-glutamyl Transferase level (GGT)

    Time frame: 6 months compared to the baseline

    Change in GGT serum level as inflammatory markers of NASH

  5. Serum total and direct bilirubin.

    Time frame: 6 months compared to the baseline

    Change in levels of serum total and direct bilirubin.

  6. Waist circumference

    Time frame: 6 months compared to the baseline

    Change in waist circumference

  7. Change in anthropometric measures

    Time frame: 6 months compared to the baseline

    including BMI etc.

  8. Lipid profile

    Time frame: 6 months compared to the baseline

    Change in serum lipids

  9. Glycated hemoglobin (HbA1C)

    Time frame: 6 months compared to the baseline

    Change in HbA1C level for patients with T2DM

  10. Fasting blood glucose level

    Time frame: 6 months compared to the baseline

    Change in fasting blood glucose for patients with T2DM

  11. Drugs adverse events

    Time frame: 6 months compared to the baseline

    Assessment of safety by reporting any adverse events

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Effectiveness and Safety of Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 17, 2022
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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