MedTrace Logo

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

NCT06677788 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-11-07

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Tarek Mohamed Mostafa, Professor of clinical pharmacy · Faculty of Pharmacy , Tanta University, Tanta, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-09-20
Completion
2024-10-15
FDA Drug
Yes

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06677788 on ClinicalTrials.gov