Evaluation of Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Obstructive Jaundice

Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of Pentoxifylline Supplementation in Patients With Hepatic and Post Hepatic Jaundice

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

Study Overview

• Status: Completed
• Conditions: Hepatobiliary Disorders
• Intervention / Treatment: Drug: Pentoxifylline

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt, 31111
    • Faculty of Pharmacy, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients age 18-70 years old.
• Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.

Exclusion Criteria:

• Pregnancy.

  • Nursing mothers.
  • Patients with increased indirect bilirubin level.
  • Patients who have Gilbert syndrome or Crigler Najjar syndrome.
  • History of intolerance and hypersensitivity to Pentoxifylline or to xanthine derivatives such as caffeine, theophylline.
  • Recent hemorrhage.
  • Patients who have risk factors potentially complicated by hemorrhage.
  • Taking anticoagulants or antiplatelet therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; 20 patients who will receive supportive treatment for jaundice only, for 3 months.
Experimental: PTX arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total antioxidant capacity (TAC) level,	Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.	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.	The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.
Adverse events and toxicity	Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5	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.	The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 19, 2025

Study Registration Dates

• First Submitted: April 18, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Jaundice; Pentoxifylline; TNF-α; Bilirubin; TAC
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperbilirubinemia; Skin Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Digestive System Diseases; Jaundice; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Purinones; Purines; Xanthines; Theobromine; Pentoxifylline
• Other Study ID Numbers: TP/RE1/24Ph-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No