Erdosteine for nonalcoholic fatty liver disease
Evaluating the Safety and Efficacy of Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease Patients
This trial will try erdosteine alongside standard therapy in adults with nonalcoholic fatty liver disease confirmed by ultrasound to see if it improves liver fat and liver health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta) |
| Trial ID | NCT07242222 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 interventional trial will enroll adults with NAFLD confirmed by upper abdominal ultrasound at Tanta University. Participants will receive either standard therapy alone or standard therapy plus erdosteine, with clinical and safety outcomes tracked during the treatment period. Key exclusions include significant alcohol intake, other causes of chronic liver disease, pregnancy, chronic kidney disease, and hypersensitivity to erdosteine. The trial will collect liver-related biomarkers and safety labs to provide preliminary evidence of tolerability and potential benefit.
Who should consider this trial
Good fit: Adults aged over 18 with NAFLD diagnosed by ultrasound who do not have significant alcohol use or other chronic liver diseases and who can attend visits at Tanta University are the intended participants.
Not a fit: Patients with other chronic liver diseases, significant alcohol intake, chronic kidney disease, pregnancy or lactation, or known hypersensitivity to erdosteine are unlikely to benefit or will be excluded.
Why it matters
Potential benefit: If successful, erdosteine could reduce liver fat or improve liver-related biomarkers and offer a new treatment option for people with NAFLD.
How similar studies have performed: Erdosteine has established antioxidant and anti-inflammatory use in respiratory disease, but its application to NAFLD is novel and supported by limited clinical evidence so far.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Either male or female adult patients (\>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US). Exclusion Criteria: Pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake \> 30 g per day in men and \> 20 g per day in women). Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, and autoimmune hepatitis. Patients suffering from chronic kidney disease, hyper/hypoparathyroidism. Hypersensitivity to erdostiene.
Where this trial is running
Tanta
- Tanta Unuversity — Tanta, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.