Prevalence and Prognosis of Drug-Induced Liver Injury

September 15, 2026 updated by: Mina Salama Tawfik Yousef, Assiut University

Prevalence and Prognosis of Drug-Induced Liver Injury at Al-Rajhi Liver Hospital

Drug-induced liver injury (DILI) is an important cause of acute liver damage that occurs when prescription medications, over-the-counter drugs, herbal products, or dietary supplements harm the liver. DILI can range from mild abnormalities in liver enzymes that cause no symptoms to severe conditions such as acute liver failure, the need for an urgent liver transplant, or death. Diagnosing DILI is often challenging because it shares symptoms with many other liver diseases, and there are currently no single specific blood tests to confirm it.

There is limited data regarding the prevalence, causative agents, and clinical outcomes of DILI among patients in Upper Egypt.

The main purpose of this study is to:

  1. Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals.
  2. Identify the most common medications, herbal preparations, and supplements causing liver injury.
  3. Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio).
  4. Evaluate patient outcomes and identify clinical and laboratory factors that predict unfavorable outcomes, such as acute liver failure, liver transplantation, or death.

The study is an observational study conducted over a two-year period using two approaches:

  • A retrospective chart review of adult patients diagnosed with DILI during the first year.
  • A prospective follow-up of consecutive adult patients who present with DILI during the second year.

Participants will receive standard medical care as directed by their treating physicians. Routine medical data, laboratory tests, imaging results, and treatment details will be recorded and analyzed to help improve the early detection, prevention, and management of DILI in clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients (aged 18 years or older) presenting to or admitted to Al-Rajhi Liver Hospital, Assiut University Hospitals, Assiut, Egypt, who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI) following exposure to a suspected prescription drug, herbal preparation, or dietary supplement.

Description

Inclusion Criteria:

  • Adult patients aged 18 years or older.

  • Patients presenting to or admitted to Al-Rajhi Liver Hospital during the study period.

  • Patients fulfilling the predefined biochemical and clinical criteria for drug-induced liver injury (DILI):

    • Alanine aminotransferase (ALT) >= 5 times the upper limit of normal (ULN); or
    • Alkaline phosphatase (ALP) >= 2 times the ULN (particularly when accompanied by elevated gamma-glutamyl transferase [GGT] and in the absence of a known bone source); or
    • ALT >= 3 times the ULN with simultaneous total bilirubin > 2 times the ULN.

  • Documented exposure to a suspected medication, herbal preparation, or dietary supplement preceding the onset of liver injury, with a compatible temporal relationship.

  • For the retrospective cohort: availability of adequate medical records to establish the diagnosis of DILI and assess clinical outcomes.

  • For the prospective cohort: provision of informed consent for study participation and follow-up (by the patient or a legally authorized representative).

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients in whom an alternative etiology of acute liver injury is clearly established (e.g., acute viral hepatitis, autoimmune hepatitis, biliary obstruction, ischemic/hypoxic hepatitis) and DILI is considered unlikely
  • Patients with insufficient clinical or laboratory data to verify whether diagnostic criteria for DILI are fulfilled
  • Patients in the retrospective cohort with inadequate outcome records where assessment of the primary clinical endpoint is not possible
  • Patients (or their legal representatives) who decline participation in the prospective cohort

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Retrospective DILI Cohort

Eligible adult patients (aged 18 years or older) evaluated at Al-Rajhi Liver Hospital during the first year of the study period who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI), identified via medical record review.
Prospective DILI Cohort

Consecutive eligible adult patients (aged 18 years or older) presenting to or admitted to Al-Rajhi Liver Hospital during the second year of the study period who fulfill the predefined clinical and biochemical criteria for drug-induced liver injury (DILI) and are followed prospectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Patients With Unfavorable DILI Outcomes
Time Frame: Up to 1 year

Proportion of patients with drug-induced liver injury who develop a composite unfavorable outcome, defined as acute liver failure (acute liver injury with hepatic coagulopathy and clinically apparent hepatic encephalopathy without pre-existing severe chronic liver disease), liver transplantation, or death attributable to severe DILI.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DILI: Prevalence & Prognosis

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