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Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Active

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

pentoxifylline (Trental SR®)

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged between 18- 60 years old.
Both sexes
Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by
1. clinical examination (obese, high body mass index).
2. radiological criteria of fatty liver (abdominal ultrasonography).
3. laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT).
The ability to give informed consent
Appropriate exclusion of other liver diseases

Exclusion Criteria:

1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study.

2. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years.

3. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors.

4. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral

Sites / Locations

Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pentoxifylline Group

Control Group

Arm Description

25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.

25 patients will receive their standard therapy only

Outcomes

Primary Outcome Measures

improvement in liver aminotransferases(ALT and AST)

Difference between last and first measurements

NAFLD fibrosis score (NFS)

Change in NAFLD fibrosis score (NFS) (lower score means better outcome).

Secondary Outcome Measures

The Aspartate (AST) to Platelet Ratio Index (APRI) score:

Change in (APRI) score (lower score means better outcome).

The Fibrosis-4 (FIB-4) values:

Change in (FIB-4) values (lower values means better outcome).

Serum Alkaline Phosphatase level (ALP)

Change in ALP serum level as inflammatory markers of NASH

Serum Gamma-glutamyl Transferase level (GGT)

Change in GGT serum level as inflammatory markers of NASH

Serum total and direct bilirubin.

Change in levels of serum total and direct bilirubin.

Waist circumference

Change in waist circumference

Change in anthropometric measures

including BMI etc.

Lipid profile

Change in serum lipids

Glycated hemoglobin (HbA1C)

Change in HbA1C level for patients with T2DM

Fasting blood glucose level

Change in fasting blood glucose for patients with T2DM

Drugs adverse events

Assessment of safety by reporting any adverse events

Full Information

NCT ID

NCT05284448

First Posted

February 16, 2022

Last Updated

March 9, 2022

Sponsor

Al-Azhar University

1. Study Identification

Unique Protocol Identification Number

NCT05284448

Brief Title

Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Official Title

Effectiveness and Safety of Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 1, 2022 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The aim of the present study is to evaluate the efficacy and safety of pentoxifylline in the treatment of non-alcoholic steatohepatitis patients.

Detailed Description

Nonalcoholic steatohepatitis(NASH) is the progressive form of Non-alcoholic fatty liver disease (NAFLD), is characterized by hepatocellular damage, inflammation, and liver fibrosis that can progress to cirrhosis, in 25% of patients, NAFLD progresses to NASH, which increases the risk for the development of cirrhosis, liver failure, and hepatocellular carcinoma. In patients with NASH, liver fibrosis is the main determinant of mortality. Pentoxifylline (PTX) is a xanthine derivative drug with a wide range of actions at the cellular and molecular level. PTX possess anti-inflammatory, antioxidant activities. PTX have potential role in improvement of NASH . Also, PTX inhibits a number of pro-inflammatory cytokines including interleukin-1, interleukin-6 and tumor necrosis factor (TNF-α ) which play an important role in the pathogenesis and progression of NASH.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NASH - Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Clinical trial, parallel, randomized, prospective, controlled study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pentoxifylline Group

Arm Type

Experimental

Arm Description

25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

25 patients will receive their standard therapy only

Intervention Type

Drug

Intervention Name(s)

pentoxifylline (Trental SR®)

Intervention Description

400 mg three times daily

Primary Outcome Measure Information:

Title

improvement in liver aminotransferases(ALT and AST)

Description

Difference between last and first measurements

Time Frame

6 months compared to the baseline

Title

NAFLD fibrosis score (NFS)

Description

Change in NAFLD fibrosis score (NFS) (lower score means better outcome).

Time Frame

6 months compared to the baseline

Secondary Outcome Measure Information:

Title

The Aspartate (AST) to Platelet Ratio Index (APRI) score:

Description

Change in (APRI) score (lower score means better outcome).

Time Frame

6 months compared to the baseline

Title

The Fibrosis-4 (FIB-4) values:

Description

Change in (FIB-4) values (lower values means better outcome).

Time Frame

6 months compared to the baseline

Title

Serum Alkaline Phosphatase level (ALP)

Description

Change in ALP serum level as inflammatory markers of NASH

Time Frame

6 months compared to the baseline

Title

Serum Gamma-glutamyl Transferase level (GGT)

Description

Change in GGT serum level as inflammatory markers of NASH

Time Frame

6 months compared to the baseline

Title

Serum total and direct bilirubin.

Description

Change in levels of serum total and direct bilirubin.

Time Frame

6 months compared to the baseline

Title

Waist circumference

Description

Change in waist circumference

Time Frame

6 months compared to the baseline

Title

Change in anthropometric measures

Description

including BMI etc.

Time Frame

6 months compared to the baseline

Title

Lipid profile

Description

Change in serum lipids

Time Frame

6 months compared to the baseline

Title

Glycated hemoglobin (HbA1C)

Description

Change in HbA1C level for patients with T2DM

Time Frame

6 months compared to the baseline

Title

Fasting blood glucose level

Description

Change in fasting blood glucose for patients with T2DM

Time Frame

6 months compared to the baseline

Title

Drugs adverse events

Description

Assessment of safety by reporting any adverse events

Time Frame

6 months compared to the baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged between 18- 60 years old. Both sexes Patients who have nonalcoholic steatohepatitis (NASH) will be diagnosed by clinical examination (obese, high body mass index). radiological criteria of fatty liver (abdominal ultrasonography). laboratory investigation (elevated liver enzymes aspartate transaminase (AST), alanine transaminase (ALT). The ability to give informed consent Appropriate exclusion of other liver diseases Exclusion Criteria: 1- Patients with other diagnosed chronic liver diseases as viral hepatitis, metabolic and genetic disorders as Hemochromatosis, Wilson disease, autoimmune hepatitis and drug induced liver disease as well as patients with recent infection and those who refused to be entitled in the study. 2. Patients will be excluded if they had a history of past excessive alcohol drinking for a period longer than 2 years at any time in the past 10 years. 3. Patients also will be excluded if they take medications known to cause steatosis or taking medications that have shown benefits in previous NASH pilot studies, including vitamin E, , thiazolidinedione, and alpha-glucosidase inhibitors. 4. Patients with a history of hypersensitivity to PTX or the methylxanthines (caffeine, theophylline, and theobromine) will be excluded, as well as those with a history of cerebral

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeinab Zalat, PhD

Organizational Affiliation

Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University(Girls, Cairo)

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Adel Gaber Bakr, PhD

Organizational Affiliation

Assistant Professor of Pharmacology and Toxicology, Al-Azhar University (Boys, Assiut)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Ahmed ElGhandour, MD

Organizational Affiliation

Assistant Professor of Internal Medicine and Gastroenterology, Faculty of Medicine, Ain-Shams University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

ahmed abomandour, Demonstrator

Organizational Affiliation

Demonstrator of Clinical Pharmacy Department, Faculty of Pharmacy, Al-Azhar University (Boys, Assiut)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Internal medicine and hepatology outpatient clinic at Ain Shams University Hospital.

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

7682538

Citation

Leoncini L, Vindigni C, Megha T, Funto I, Pacenti L, Musaro M, Renieri A, Seri M, Anagnostopoulos J, Tosi P. Epstein-Barr virus and gastric cancer: data and unanswered questions. Int J Cancer. 1993 Apr 1;53(6):898-901. doi: 10.1002/ijc.2910530605.

Results Reference

background

PubMed Identifier

3088890

Citation

Girolami A. Tentative and updated classification of factor X variants. Acta Haematol. 1986;75(1):58-9. doi: 10.1159/000206084. No abstract available.

Results Reference

background

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Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

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