Hepatic and Post Hepatic JaundicePhase 2NCT06236165
Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
A Phase 2 study testing N-acetylcysteine in people with Hepatic and Post Hepatic Jaundice, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic and Post Hepatic Jaundice
- What is being tested?
- N-acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Feb 2024to 22 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18-70 years old.
- Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- N-acetylcysteine
- Keywords
- Jaundice, N-acetylcysteine, TAC, TNF-α, Bilirubin
- Medical subject headings
- Jaundice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
Patients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Adverse events and toxicity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.
Measured: 3 months.
Change in total antioxidant capacity (TAC) level
Assessment of total antioxidant capacity (TAC) level by ELISA Kits according to manufacturer's instructions.
Measured: 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)
Assessment of tumor necrosis factor alpha (TNF-α) level by ELISA Kits according to manufacturer's instructions
Measured: 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
Assessment of liver-fatty acid binding protein (L-FABP) level by ELISA Kits according to manufacturer's instructions.
Measured: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start14 Feb 2024
- Primary completion22 Jan 2025
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic and Post Hepatic JaundiceStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Hussein Mohamed, Tanta University
- Investigators
- Samah Hussein, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236165
- Sponsor's protocol ID
- 00543/2024
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
- ClinicalTrials.gov ID
- NCT06236165
- Acronym / sponsor ID
- 00543/2024
- Conditions
- Hepatic and Post Hepatic Jaundice
- Keywords
- Jaundice, N-acetylcysteine, TAC, TNF-α, Bilirubin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –22 patients who will receive supportive treatment for jaundice only, for 3 months. |
| NAC arm | Experimental | Drug: N-acetylcysteine22 patients who will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 18-70 years old.
- Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteinePatients will receive oral N-acetylcysteine 600 mg twice daily in addition to supportive treatment, for 3 months. | Drug | NAC arm |
Primary outcome
The change from baseline in (Total and Direct bilirubin)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
measurement of (Total and Direct bilirubin) in mg/dL from blood samples will be assessed for all participants.
The change from baseline in alanine transaminase (ALT), aspartate transaminase (AST) and alkaline phosphatase (ALP)
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
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.
4 secondary outcomes
Patients' symptoms, adverse events and toxicity
Time frame: 3 months.
Change in total antioxidant capacity (TAC) level
Time frame: 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)
Time frame: 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
Time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samah Hussein principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetylcysteine in people with Hepatic and Post Hepatic Jaundice, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in (Total and Direct bilirubin) (time frame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.