Skip to content

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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202410748072574
Enrollment
52
Registered
2024-10-30
Start date
2022-01-03
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System

Interventions

Vitamin E group
Roflumilast group

Sponsors

Tanta University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1-Patients with Cytokeratine level >240 IU/L. 2-Adult patient (age > 18 years old). 3-Both sex. 4-Overweight and obese subjects. 5-Patients with evidence of steatosis through imaging. 6-Patient with mild to moderate elevation in aminotransferase activity (>2 ,but 36. 8-Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance) of 2 or 3 . 9-Patients with fibroscan score >7Kpa and < 12.5 Kpa (F2 – F3).

Exclusion criteria

Exclusion criteria: 1- Alcohol consumers. 2-Smokers. 3-Patients with Wilson`s disease and hemochromatosis. 4-Patients with viral hepatitis. 5-Patients with cirrhosis. 6-Patients with inflammatory diseases. 7-Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy). 8-Patients on medications that interfere with lipid and carbohydrate metabolism. 9-Patients on stateogenic medications, pregnant and lactating women and females on oral contraceptive pills.

Design outcomes

Primary

MeasureTime frame
The primary outcome was the change in liver stiffness measurement (LSM) (fibro scan score).

Secondary

MeasureTime frame
The secondary outcome was the change in the biological markers .

Countries

Egypt

Contacts

Public ContactSherif Mohamed Abd elsalam

Professor of tropical medicine and infectious diseaseFaculty of MedicineTanta UniversityTanta Egypt

sheriefabdelsalam@yahoo.com01147773440

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026