Steatohepatitis, NonalcoholicPhase 1/2NCT04080947
The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis
A Phase 1/2 study testing Montelukast group in people with Steatohepatitis, Nonalcoholic, run by Sadat City University at 1 site in Egypt.
Trial summary
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Steatohepatitis, Nonalcoholic
- What is being tested?
- Montelukast group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2019to 15 Mar 2022
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.
Who cannot join
- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.
- Conditions
- Steatohepatitis, Nonalcoholic
- Being tested
- Control group, Montelukast group
- 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.
Control groupDrug
patients received matching-image placebo once daily at bedtime for 12 weeks.
Montelukast groupDrug
patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 26 patients will receive placebo (Control group) Receives: Drug: Control group |
| Montelukast group | Experimental | 26 patients will receive montelukast 10 mg/ day Receives: Drug: Montelukast group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibro-scan score
change in liver stiffness measurement (Fibro-scan score)
Measured: At baseline and after 12 weeks of intervention
Liver Panel
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
Measured: after 12 weeks of intervention
Secondary outcomes (6)
HOMA-IR
Homeostatic Model Assessment of Insulin Resistance
Measured: after 12 weeks of intervention
8-OHdG
Serum level of 8-OHdG
Measured: after 12 weeks of intervention
TNF-Alpha
Serum level of TNF-Alpha
Measured: after 12 weeks of intervention
hyaluronic acid
Serum level of hyaluronic acid
Measured: after 12 weeks of intervention
TGF-β1
Serum level of TGF-β1
Measured: after 12 weeks of intervention
Assessment of drugs tolerability: Side effects
Side effects of montelukast
Measured: after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Aug 2019
- Primary completion31 Aug 2021
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Steatohepatitis, NonalcoholicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Samy Abdallah, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080947
- Sponsor's protocol ID
- 002017
- Status last verified
- Mar 2022
- First submitted
- 31 Aug 2019
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Abdallah MS, Eldeen AH, Tantawy SS, Mostafa TM. The leukotriene receptor antagonist montelukast in the treatment of non-alcoholic steatohepatitis: A proof-of-concept, randomized, double-blind, placebo-controlled trial. Eur J Pharmacol. 2021 Sep 5;906:174295. doi: 10.1016/j.ejphar.2021.174295. Epub 2021 Jun 30.
PubMed 34214585
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04080947
- Acronym / sponsor ID
- 002017
- Conditions
- Steatohepatitis, Nonalcoholic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Control group26 patients will receive placebo (Control group) |
| Montelukast group | Experimental | Drug: Montelukast group26 patients will receive montelukast 10 mg/ day |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria were adult patients (age >18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (> 2 but <5 times upper limit of normal), hepatic steatosis index (HIS) >36, Fibro-scan score >7 kpa and <12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.
Key exclusion criteria (1 listed)
- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control grouppatients received matching-image placebo once daily at bedtime for 12 weeks. | Drug | Control group |
| Montelukast grouppatients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks. | Drug | Montelukast group |
Primary outcome
Fibro-scan score
Time frame: At baseline and after 12 weeks of intervention
change in liver stiffness measurement (Fibro-scan score)
Liver Panel
Time frame: after 12 weeks of intervention
Alanine aminotransferase (ALT) and Aspartate Aminotransferase (AST) will be evaluated in U/L
6 secondary outcomes
HOMA-IR
Time frame: after 12 weeks of intervention
8-OHdG
Time frame: after 12 weeks of intervention
TNF-Alpha
Time frame: after 12 weeks of intervention
hyaluronic acid
Time frame: after 12 weeks of intervention
TGF-β1
Time frame: after 12 weeks of intervention
Assessment of drugs tolerability: Side effects
Time frame: after 12 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Derived from this study: PubMed 34214585Abdallah MS, Eldeen AH, Tantawy SS, Mostafa TM. The leukotriene receptor antagonist montelukast in the treatment of non-alcoholic steatohepatitis: A proof-of-concept, randomized, double-blind, placebo-controlled trial. Eur J Pharmacol. 2021 Sep 5;906:174295. doi: 10.1016/j.ejphar.2021.174295. Epub 2021 Jun 30.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Montelukast group in people with Steatohepatitis, Nonalcoholic, run by Sadat City 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 1 inclusion and 1 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 16 Mar 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Fibro-scan score (time frame: At baseline and after 12 weeks of intervention). 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 NCT04080947, which also lists 1 linked publication.
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 16 Mar 2022.