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NCT Number: NCT06677788

Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

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.

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Key information

Conditions

Non-alcoholic Steatohepatitis (NASH) Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tanta University

Tanta, Gharbia Governorate, 6620010, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Cytokeratine level >240 IU/L.
  • Adult patient (age > 18 years old).
  • Both sex.
  • Overweight and obese.
  • Patients with evidence of steatosis through imaging.
  • Patient with mild to moderate elevation in aminotransferase activity (>2 ,but <5 times upper limit of normal ).
  • Patient with Hepatic steatosis index (HSI) > 36.
  • Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or 3.
  • Fibroscan score >7Kpa and < 12.5 Kpa (F2 - F3).

Exclusion criteria

  • Alcohol consumer and smokers
  • Patients with Wilson's disease and hemochromatosis .
  • Patients with viral hepatitis.
  • Patients with cirrhosis .
  • Patients with inflammatory diseases .
  • Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
  • Patients on medications that interfere with lipid and carbohydrate metabolism..
  • Patients on stateogenic medications.
  • Pregnancy and lactating women.
  • Females on oral contraceptive pills.

Treatment and study plan

Roflumilast 500 Mcg Oral Tablet

Drug

Patients in this group received roflumilast 500 μg once daily for three months.

Vitamin E capsule

Drug

vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily

Primary outcomes

  1. Change in liver stiffness measurement (LSM) measured by fibroscan score

    Time frame: 12 weeks following the end of treatment

    Liver Stiffness measurement (LSM) by fibro-scan. Transient elastography (Fibroscan, Echosens, Paris) was used to assess liver stiffness depending up-on the method formerly prescribed .Through a single independent operator, at least ten valid measurements were obtained for each patient. Results were included in the final analysis only if the following three criteria were met: at least ten valid measurements, success rate >60% and the interquartile range (IQR)-to-liver stiffness ratio was ≤0.30. The median values of the validated measurements for each patient were representative to the liver stiffness and expressed in units of kilopascals (kPa)

Secondary outcomes

  1. The change in liver panel parameters

    Time frame: 3 months after treatment

    Blood sample collection and biochemical measurement of Approximately 10 ml of venous blood was taken from each patient after overnight fasting by sterile venipuncture, without frothing and after minimal venous stasis using disposable syringes. Blood samples were delivered in a vacutainer serum separator tubes. Immediate centrifugation at 3000 rpm was performed and then the serum was separated and divided into two portions. The first portion was used for determination of fasting blood glucose (glucose oxidase method), liver enzymes aspartate transaminase "AST", alanine transaminase "ALT" and gamma-glutamyl transaminase "GGT" (spectrophotometerially) and lipid panel (enzymatic colorimeteric method).

  2. Improvement in HOMA IR

    Time frame: 12 weeks following the end of treatment

    HOMA-IR is calculated as [Fasting Insulin (μg/ml)]*[Fasting Glucose (mmol/l)]/22.5,HOMA-IR values between 0.5 and 1.4 are considered normal, ≥1.9 are indicative of early IR, and ≥2.9 indicate IR

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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