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NASH - Nonalcoholic SteatohepatitisPhase 3NCT05284448

Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

A Phase 3 study testing pentoxifylline (Trental SR®) in people with NASH - Nonalcoholic Steatohepatitis, run by Al-Azhar University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
NASH - Nonalcoholic Steatohepatitis
What is being tested?
pentoxifylline (Trental SR®)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Feb 2022to 1 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

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

    Cairo

Other trials in Egypt

About this study

Official title: Effectiveness and Safety of Pentoxifylline in Treatment of Patients With Nonalcoholic Steatohepatitis

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

Read the 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.

Being tested
pentoxifylline (Trental SR®)
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pentoxifylline (Trental SR®)Drug

    400 mg three times daily

Study groups in NCT05284448
Study groupRoleWhat they receive
Pentoxifylline GroupExperimental25 patients will receive pentoxifylline (Trental SR®) 400 mg three times daily with their standard therapy for 6 months.
Receives: Drug: pentoxifylline (Trental SR®)
Control GroupNo intervention25 patients will receive their standard therapy only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. improvement in liver aminotransferases(ALT and AST)

    Difference between last and first measurements

    Measured: 6 months compared to the baseline

  2. NAFLD fibrosis score (NFS)

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

    Measured: 6 months compared to the baseline

Secondary outcomes (11)

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

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

    Measured: 6 months compared to the baseline

  2. The Fibrosis-4 (FIB-4) values:

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

    Measured: 6 months compared to the baseline

  3. Serum Alkaline Phosphatase level (ALP)

    Change in ALP serum level as inflammatory markers of NASH

    Measured: 6 months compared to the baseline

  4. Serum Gamma-glutamyl Transferase level (GGT)

    Change in GGT serum level as inflammatory markers of NASH

    Measured: 6 months compared to the baseline

  5. Serum total and direct bilirubin.

    Change in levels of serum total and direct bilirubin.

    Measured: 6 months compared to the baseline

  6. Waist circumference

    Change in waist circumference

    Measured: 6 months compared to the baseline

  7. Change in anthropometric measures

    including BMI etc.

    Measured: 6 months compared to the baseline

  8. Lipid profile

    Change in serum lipids

    Measured: 6 months compared to the baseline

  9. Glycated hemoglobin (HbA1C)

    Change in HbA1C level for patients with T2DM

    Measured: 6 months compared to the baseline

  10. Fasting blood glucose level

    Change in fasting blood glucose for patients with T2DM

    Measured: 6 months compared to the baseline

  11. Drugs adverse events

    Assessment of safety by reporting any adverse events

    Measured: 6 months compared to the baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2022
  2. Study start1 Feb 2022
  3. Primary completion1 Sep 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinical trial, parallel, randomized, prospective, controlled study
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05284448
Sponsor's protocol ID
312
Status last verified
Jun 2024
First submitted
16 Feb 2022
Last updated
21 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 7682538

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

    PubMed 3088890

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pentoxifylline (Trental SR®) in people with NASH - Nonalcoholic Steatohepatitis, run by Al-Azhar University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

improvement in liver aminotransferases(ALT and AST) (time frame: 6 months compared to the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284448, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.

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