Clinical trial NCT06677788: Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH
Official title: Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Keywords: NASH
Roflumilast
LSM
TNF-α
MDA
TGF-ß1
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 55
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in liver stiffness measurement (LSM) measured by fibroscan score
timeFrame: 12 weeks following the end of treatment
Secondary outcomes:
measure: The change in liver panel parameters
timeFrame: 3 months after treatment
measure: Improvement in HOMA IR
timeFrame: 12 weeks following the end of treatment
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: Gharbia
Study officials:
affiliation: Faculty of Pharmacy , Tanta University, Tanta, Egypt
name: Tarek Mohamed Mostafa, Professor of clinical pharmacy
role: STUDY_CHAIR
References: