NCT06677788

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH. Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.

Conditions

• Non-Alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	Roflumilast 500 Mcg Oral Tablet	Patients in this group received roflumilast 500 μg once daily for three months.
DRUG	Vitamin E capsule	vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily

Timeline

• Start date: 2022-04-01
• Primary completion: 2024-09-20
• Completion: 2024-10-15
• First posted: 2024-11-07
• Last updated: 2024-11-07

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study