Comparing the Effects of Vitamin E, Ursodeoxycholic Acid and Pentoxyfylline on Egyptian Non-alcoholic Steatohepatitis (NASH) Patients

NCT04977661 | Completed Phase 4 DMC

• 1 other identifier: 154569224578
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

We conducted a 3-month, randomized, single-blind study in 102 Egyptian NASH patients who were divided into three groups; group 1 included 34 patients received Vit. E 400 mg twice a day, group 2 included 34 patients received UDCA 250 mg twice a day and group 3 included 34 patients received PTX 400 mg twice daily for 3 months. The following parameters were measured both before and after intervention intake; liver aminotransferases (AST, ALT), cytokine and chemokine (IL6 and CCL2/MPC-1), albumin, total bilirubin, direct bilirubin, total cholesterol, triglyceride, LDL, HDL.

Conditions

Nonalcoholic Steatohepatitis (NASH)

Keywords

Vitamin E, Ursodeoxycholic acid, Pentoxifylline, NASH

Outcome Measures

Primary Outcomes (1)

• Resolution of NASH

  Relieve clinical symptoms and prevent progression

  3 months

Secondary Outcomes (1)

• Normalization of hepatic aminotransferases(ALT and AST)

  3 months

Study Arms (3)

Group1

ACTIVE COMPARATOR

Group I (n = 34) received 400 IU Vitamin E (Vitamin E 400 IU®, MEPACO Pharmaceutical Company, Sharqia, Egypt) twice daily for 3 month

Drug: Vitamin E

Group2

ACTIVE COMPARATOR

Group II (n =34) received 250 mg Ursodeoxycholic acid (Ursofalk 250 mg®, MINAPHARM Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months

Drug: Ursodeoxycholic acid

Group3

ACTIVE COMPARATOR

Group III (n = 34) received 400 mg sustained release (SR) Film-Coated Tablets of pentoxifylline (Trental 400 mg®, SANOFI Pharmaceutical Company, Cairo, Egypt) twice daily for 3 months

Drug: Pentoxifylline

Interventions

Vitamin E DRUG

Vitamin E is one of the body's most effective chain-breaking antioxidants that has shown to delay the pathogenesis of NASH.

Also known as: Alpha-Tocopherol

Group1

Ursodeoxycholic acid DRUG

is a metabolic by-product of intestinal bacteria and has been proven to be useful in the non-surgical treatment of cholesterol gallstones and primary biliary cirrhosis (PBC)

Also known as: Ursofalk

Group2

Pentoxifylline DRUG

it is a well-tolerated medication that improves blood viscosity and erythrocyte rheological characteristics in individuals with peripheral vascular disease 20. In addition, PTX is a nonspecific phosphodiesterase inhibitor that increases cyclic adenosine monophosphate (cAMP) levels while decreasing TNF-a gene transcription

Also known as: Trental

Group3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: \> 18 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were enrolled in the study
• if they are \> 18 years old
• had evidence for NASH; persistently elevated alanine aminotransferase (ALT) \>1.5 times the upper limit of normal)
• imaging (ultrasound) showing fatty infiltration, and histological evidence of NASH after biopsy (macrovascular steatosis, ballooning degeneration of hepatocytes, scattered lobular inflammation and apoptotic bodies).

You may not qualify if:

• Patients were ruled out if they had
• history of alcohol dependence
• treatment with drugs known to induce NASH (e.g. amiodarone, calcium channel blocker, tamoxifen, oral anticoagulation, methotrexate , steroids and estrogen)
• positive serologic markers for known chronic liver diseases (hepatitis B surface antigen, anti-hepatitis C virus antibody antinuclear antibody)
• human immunodeficiency virus (HIV) infection
• Diabetes
• decompensated liver disease defined as serum bilirubin level \>1 mg/dL, albumin level ˂3.5 g/dL, and international normalized ratio (INR) ≥1.7.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Hepatology, gastroenterology and infectious diseases department at Kafrelsheikh University Hospital

Cairo, 33511, Egypt

Location

Related Publications (1)

• Younossi Z, Tacke F, Arrese M, Chander Sharma B, Mostafa I, Bugianesi E, Wai-Sun Wong V, Yilmaz Y, George J, Fan J, Vos MB. Global Perspectives on Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis. Hepatology. 2019 Jun;69(6):2672-2682. doi: 10.1002/hep.30251.

  PMID: 30179269 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Vitamin E; alpha-Tocopherol; Ursodeoxycholic Acid; Pentoxifylline

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tocopherols; Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Theobromine; Xanthines; Purinones; Purines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: (single blind study) : Participants did not know the treatment which was given
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr assistant lecturer

Model Details: prospective, randomized, and single blind study

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 27, 2021
• Study Start: February 1, 2020
• Primary Completion: May 20, 2020
• Study Completion: January 10, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Locations

EG (1)