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

NCT06236165 | Completed Phase 2

• 1 other identifier: 00543/2024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic and Post Hepatic Jaundice

Keywords

Jaundice; N-acetylcysteine; TAC; TNF-α; Bilirubin

Outcome Measures

Primary Outcomes (2)

• 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 after 3 months.

• The change from baseline in alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)

  measurement of alanine transaminase (ALT), aspartate transaminase (AST) 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 Outcomes (4)

• Patients' symptoms, adverse events and toxicity

  3 months.

• 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.

• Change in liver-fatty acid binding protein (L-FABP) level

  The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months

Study Arms (2)

Control arm

NO INTERVENTION

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

NAC arm

EXPERIMENTAL

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

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

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

NAC 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.
• History of known hypersensitivity to N-acetylcysteine.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy, Tanta University

Tanta, 31111, Egypt

Location

MeSH Terms

Conditions

Jaundice

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Samah Hussein

  Tanta University

  PRINCIPAL INVESTIGATOR

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: Master degree in Clinical Pharmacy

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: February 14, 2024
• Primary Completion: January 22, 2025
• Study Completion: January 22, 2025
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)