Clinical trial

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

Name

00543/2024

Description

Investigating the efficacy, safety, and molecular mechanism of both N-acetylcysteine and Pentoxifylline supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice.

Trial arms

Trial start

2024-02-14

Estimated PCD

2024-08-01

Trial end

2025-02-01

Status

Recruiting

Phase

Early phase I

Treatment

N-acetylcysteine

Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.

Arms:

NAC arm

Pentoxifylline

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

Arms:

PTX arm

Size

Primary endpoint

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 after 3 months.

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 after 3 months.

Eligibility criteria

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. * History of known hypersensitivity to N-acetylcysteine.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ESTIMATED'}}

Updated at

2024-02-15

1 organization

2 products

1 indication

Organization

Product

Indication

Product