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

Phase 3

Completed

• Conditions: Hepatobiliary Disorders
• Interventions: Drug: Pentoxifylline

• Registration Number: NCT06944704
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-04-03
• Primary Completion: 2025-03-19
• Study Completion: 2025-03-19
• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-18
• Study First Posted: 2025-04-25
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.
  • Patients with Child Paugh C score (10-15 point).
  • 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTX arm	Pentoxifylline	20 patients who will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.

Primary Outcome Measures

Name	Time	Method
Change in total antioxidant capacity (TAC) level,	The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.	Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.
Change in tumor necrosis factor alpha (TNF-α)	The participants will be assessed before initiation of the study (baseline), and at the end of the study up to 12 weeks.	Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions.

Secondary Outcome Measures

Name	Time	Method
Adverse events and toxicity	up to 12 weeks	Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5
Follow up of liver function	The participants will be assessed before initiation of the study (baseline), and at the end of the study up to12 weeks.	measurement of alanine transaminase (ALT) and aspartate transaminase (AST) both in U/L from blood samples will be assessed for all participants.

Trial Locations

Locations (1)

Faculty of Pharmacy, Tanta University; 🇪🇬 Tanta, Egypt