NCT06677788CompletedPhase 2
Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH
Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis
Source: ClinicalTrials.gov · Last updated 7 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 1 Nov 2024
- Start date
- 1 Apr 2022
- Primary completion date
- 20 Sept 2024
- Lead sponsor
- Tanta University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06677788
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 55
- From 1 Apr 2022 to the primary completion date, 20 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on medications that interfere with lipid and carbohydrate metabolism..
- Patients on stateogenic medications.
Other illness
- Patients with Wilson's disease and hemochromatosis .
- Patients with viral hepatitis.
- Patients with inflammatory diseases .
Lab values
- Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
Other
- Alcohol consumer and smokers
- Patients with cirrhosis .
- Pregnancy and lactating women.
- Females on oral contraceptive pills.
Who the study is looking for
- 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).
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tanta university Coordinator of this site? Confirm its status | Tanta | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.