Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.
Cairo, Egypt
NCT Number: NCT05284448
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 3
Cairo, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
400 mg three times daily
Time frame: 6 months compared to the baseline
Difference between last and first measurements
Time frame: 6 months compared to the baseline
Change in NAFLD fibrosis score (NFS) (lower score means better outcome).
Time frame: 6 months compared to the baseline
Change in (APRI) score (lower score means better outcome).
Time frame: 6 months compared to the baseline
Change in (FIB-4) values (lower values means better outcome).
Time frame: 6 months compared to the baseline
Change in ALP serum level as inflammatory markers of NASH
Time frame: 6 months compared to the baseline
Change in GGT serum level as inflammatory markers of NASH
Time frame: 6 months compared to the baseline
Change in levels of serum total and direct bilirubin.
Time frame: 6 months compared to the baseline
Change in waist circumference
Time frame: 6 months compared to the baseline
including BMI etc.
Time frame: 6 months compared to the baseline
Change in serum lipids
Time frame: 6 months compared to the baseline
Change in HbA1C level for patients with T2DM
Time frame: 6 months compared to the baseline
Change in fasting blood glucose for patients with T2DM
Time frame: 6 months compared to the baseline
Assessment of safety by reporting any adverse events
Al-Azhar University
Other
Effectiveness and Safety of Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis
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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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