ClinicalTrials.gg
Not yet recruitingNCT07900100Updated Oct 28, 2026

Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.

A Phase 2/3 interventional study of Placebo and Rupatadin in NAFLD (Nonalcoholic Fatty Liver Disease), sponsored by Tanta University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Tanta University · Phase 2/3, Interventional, and Treatment

Updated Oct 28, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2/3
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University — 6 open to participants now, 8 under way, 4 of them phase 3. Non-alcoholic Fatty Liver Disease · Tanta University.

Planned enrollment
3rd of 12
60 · median 58
Started
2026
with 1 other
Phase 2/3
2 of 13
2 open now
Registered
12th of 13
by date

Among the 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University, this one is the 3rd largest by planned enrollment of the 12 interventional ones that give a count, is one of 2 that started in 2026, is one of 2 in phase 2/3, and was the 12th registered.

Non-alcoholic Fatty Liver Disease

1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.

Browse Non-alcoholic Fatty Liver Disease studies →

Open to participants now

6 of the 13 studies in Non-alcoholic Fatty Liver Disease by Tanta University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study summary

NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption >30 g for men and >20 g for women

03

Conditions studied

  • NAFLD (Nonalcoholic Fatty Liver Disease)
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).

Exclusion criteria

Exclusion Criteria:

  • Pregnant and/or lactating women. Excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women).

Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, and hepatitis.

Patients suffering from chronic kidney disease, hyper/hypoparathyroidism, congestive heart failure, and cardiovascular disease.

to rupatadine.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Treatment arm

    30 patients received the standard conventional therapy in addition to placebo for 3 months.

    Drug: Placebo

  • Active comparator
    Rupatadine group

    30 patients were given the standard conventional therapy plus rupatadine 10 mg once daily.

    Drug: Rupatadin

Interventions

  • DrugPlacebo

    Placebo drug will have the same look and taste of the other treatment

  • DrugRupatadin

    Rupatadine (RUP), an H1 receptor antagonist, also inhibits the actions of platelet activation factor (PAF) and is particularly useful in allergic rhinitis and urticaria

06

What researchers measure

Primary outcomes

  1. The change in the degree of steatosis in the Ultra Sound

    The change in the degree of steatosis in the Ultra Sound

    Time frame: 3 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Jun 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartEst.
Oct 25, 2026
Primary completionEst.
Jun 20, 2027
CompletionEst.
Jul 20, 2027
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07900100
Lead sponsor
Tanta University
Responsible party
Mostafa Bahaa (Lecturer, Tanta University) — Principal investigator
First posted
Oct 28, 2026
Start date
Oct 25, 2026 (estimated)
Primary completion
Jun 20, 2027 (estimated)
Completion
Jul 20, 2027 (estimated)
Last update
Oct 28, 2026

Study contacts

Mostafa Bahaa, PhD
Contact
mbahaa@horus.edu.eg
01025538337

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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