Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2024-10-15

Brief Summary

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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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Detailed Description

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Conditions

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Non-Alcoholic Steatohepatitis (NASH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study was a randomized controlled parallel study. Patients were recruited from out-patient clinic of Tropical medicine department, Tanta university hospital, Tanta, Egypt. The study involved 55 patients with NASH who were randomized using sealed envelope methods with assignment codes for each available allocation 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. The study duration was 3 months whereas patients were assessed at baseline and 3 months after intervention. The study was conducted following the ethical standards of Helsinki declaration in 1964 and its later amendments. The study was approved by Research Ethical committee of Tanta University (approval code:35336/3/22).participants gave their written informed consent.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Roflumilast group (n=31)

Arm Description: 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 homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.

Group Type ACTIVE_COMPARATOR

Roflumilast 500 Mcg Oral Tablet

Intervention Type DRUG

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

Vitamin E group or control group (n=24)

vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily. 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 homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.

Group Type ACTIVE_COMPARATOR

Vitamin E capsule

Intervention Type DRUG

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

Interventions

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Roflumilast 500 Mcg Oral Tablet

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

Intervention Type DRUG

Vitamin E capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No