A Phase 2 interventional study of Pentoxifylline in Hepatobiliary Disorders, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Tanta University · Phase 2, Interventional, and Treatment
Investigating the efficacy, safety, and molecular mechanism of Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice
406 studies on the registry are indexed under Digestive System Diseases; 79 are open to participants now.
This study's enrollment of 45 is below the median of 85 across 288 interventional studies indexed under Digestive System Diseases.
Browse Digestive System Diseases studies →Tanta University is the lead sponsor of 1,010 studies on the registry; 321 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Pregnancy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 patients who will receive supportive treatment for jaundice only, for 3 months.
20 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.
Drug: Pentoxifylline
Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.
The change from baseline in (Total and Direct bilirubin)
measurement of(Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.
The change from baseline in aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP)
measurement of aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) all in U/L from blood samples will be assessed for all participants.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Adverse events and toxicity
Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5
Time frame: up to 12 weeks
Change in total antioxidant capacity (TAC) level,
Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in tumor necrosis factor alpha (TNF-α)
Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Change in liver-fatty acid binding protein (L-FABP)
Assessment of liver-fatty acid binding protein (L-FABP) level by ELISA Kits according to manufacturer's instructions.
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Plan to share: No — Individual participant data will not be publicly shared to ensure participant privacy and confidentiality, as explicit consent for secondary data sharing was not obtained during the study enrollment.
No publications or documents are linked to this record.
Ran from Apr 2025 to primary completion in Mar 2026, 10 months.
Of 42 phase 2 interventional studies under Digestive System Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 55. This study's 10 months is below that.
Digestive System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 30, 2026: start Apr 2024 → Apr 2025, primary completion Mar 2025 → Mar 2026 and completion Mar 2025 → Mar 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pentoxifylline