Drug-Induced Liver InjuryNCT07830901
Prevalence and Prognosis of Drug-Induced Liver Injury
An observational study of Drug-Induced Liver Injury, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug-Induced Liver Injury
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
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 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
About this study
Official title: 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.
Read more
The main purpose of this study is to:
- Determine the hospital-based prevalence of DILI among adult patients attending Al-Rajhi Liver Hospital, Assiut University Hospitals.
- Identify the most common medications, herbal preparations, and supplements causing liver injury.
- Categorize the patterns of liver injury (hepatocellular, cholestatic, or mixed) using standardized biochemical calculations (R-ratio).
- 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.
- Conditions
- Drug-Induced Liver Injury
- Keywords
- DILI, Hepatotoxicity, RUCAM, Acute Liver Failure, Drug-Induced Liver Injury Pattern
- Medical subject headings
- Chemical and Drug Induced Liver Injury, Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Unfavorable DILI Outcomes
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Induced Liver InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Salama Tawfik Yousef, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830901
- Sponsor's protocol ID
- DILI: Prevalence & Prognosis
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No