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

NCT06944704 | Completed Phase 2

• 1 other identifier: TP/RE1/24Ph-1
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatobiliary Disorders

Keywords

Jaundice; Pentoxifylline; TAC; TNF-α; Bilirubin

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (2)

• 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.

• Adverse events and toxicity

  up to 12 weeks

Study Arms (2)

Control arm

NO INTERVENTION

20 patients who will receive supportive treatment for jaundice only, for 3 months.

PTX arm

EXPERIMENTAL

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

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

Patients will receive oral Pentoxifylline 400 mg twice daily in addition to supportive treatment, for 3 months.

PTX arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy, Tanta University

Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Digestive System Diseases; Jaundice

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, M.Sc. in Clinical Pharmacy

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: April 3, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 19, 2025
• Last Updated: July 30, 2025

Record last verified: 2024-01

Locations

EG (1)