NCT05573204Active, not recruitingPhase 2
Comparative Study Between Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis
Comparative Study Evaluating the Outcome of Obeticholic Acid Versus Vitamin E in Patients with Non-alcoholic Steatohepatitis Without Cirrhosis
Source: ClinicalTrials.gov · Last updated 10 Jan 2025
Brief summary (registry, in English)
This study aims at evaluating and comparing the protective outcomes of using Obeticholic acid versus Vitamin E in NASH patients without cirrhosis. The intervention is 6-months duration and the study will assess the efficacy of either drug as fibrosis improvement (≥ 1 stage) with no worsening of NASH or NASH resolution with no worsening of fibrosis with the study considered successful if either 1ry end point is met. . Also, assessment of biochemical markers related to steatosis, inflammation, oxidative stress, insulin resistance and liver fibrosis will be done.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 5 Oct 2022
- Start date
- 1 Sept 2021
- Primary completion date
- 25 Oct 2026
- Lead sponsor
- Tanta University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05573204
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 59
- From 1 Sept 2021 to the primary completion date, 25 Oct 2026
- 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or planned bariatric surgery.
- Use of other drugs known to have possible positive effects on steatosis.
Other illness
- Current or history of significant alcohol consumption.
- Use of drugs historically associated with nonalcoholic fatty liver disease (NAFLD) (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, and other known hepatotoxins).
- Evidence of other forms of chronic liver disease as Hepatitis B, Hepatitis C, Wilson's disease, Alpha-1-antitrypsin(A1AT) deficiency, Hemochromatosis, drug-induced liver disease.
Lab values
- Uncontrolled diabetes defined as Hemoglobin A1c 9.5% or higher.
- Serum creatinine of 2.0 mg/dL or greater.
Other
- Pregnancy, planned pregnancy, potential for pregnancy and unwillingness to use effective birth control during the trial and breast feeding.
Who the study is looking for
- Males or females aged ≥18 years.
- All patients are diagnosed to have fatty liver grading 1, 2 or 3 on abdominal ultrasound with Hepatic steatosis index \> 36 to be considered as a NAFLD patient.
- Confirmed diagnosis of NASH using at least three of the following non-invasive tests:
- HAIR score
- Fibroscan detecting steatosis with F0-3 fibrosis stage
- Cytokeratin-18 \>240 U/L
- Mild to moderate elevation of serum aminotransferases (\>2 but \<5 times upper normal limit)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Tropical Medicine and Infectious Diseases, Faculty of Medicine,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.