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

Tanta University

Status and phase: Completed; Phase 2

Conditions: Hepatobiliary Disorders

Treatments: Drug: Pentoxifylline

Study type: Interventional

Funder types: Other

Identifiers

NCT06944704

TP/RE1/24Ph-1

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Control arm

No Intervention group

Description:

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

PTX arm

Experimental group

Description:

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

Treatment:

Drug: Pentoxifylline