Non-Alcoholic Steatohepatitis (NASH)Phase 2NCT06677788
Evaluating the Efficacy and Safety of Roflumilast in Patients with NASH
A Phase 2 study testing Roflumilast 500 Mcg Oral Tablet and Vitamin E capsule in people with Non-Alcoholic Steatohepatitis (NASH), run by Tanta University at 1 site in Egypt.
Trial summary
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-Alcoholic Steatohepatitis (NASH)
- What is being tested?
- Roflumilast 500 Mcg Oral Tablet and Vitamin E capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 15 Oct 2024
- Phase
- Phase 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Cytokeratine level >240 IU/L.
- Adult patient (age > 18 years old).
- Both sex.
- Overweight and obese.
- Patients with evidence of steatosis through imaging.
- Patient with mild to moderate elevation in aminotransferase activity (>2 ,but <5 times upper limit of normal ).
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- Patient with Hepatic steatosis index (HSI) > 36.
- Patient with HAIR ( hypertension ,alanine aminotransferase level ,insulin resistance ) of 2 or 3.
- Fibroscan score >7Kpa and < 12.5 Kpa (F2 - F3).
Who cannot join
- Alcohol consumer and smokers
- Patients with Wilson's disease and hemochromatosis .
- Patients with viral hepatitis.
- Patients with cirrhosis .
- Patients with inflammatory diseases .
- Patients with other comorbid disease that elevate transaminases (congestive heart failure and malignancy).
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- Patients on medications that interfere with lipid and carbohydrate metabolism..
- Patients on stateogenic medications.
- Pregnancy and lactating women.
- Females on oral contraceptive pills.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.
Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months.
Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Being tested
- Roflumilast 500 Mcg Oral Tablet, Vitamin E capsule
- Keywords
- NASH, Roflumilast, LSM, TNF-α, MDA, TGF-ß1
- 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.
Roflumilast 500 Mcg Oral TabletDrug
Patients in this group received roflumilast 500 μg once daily for three months.
Vitamin E capsuleDrug
vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Roflumilast group (n=31) | Active comparator | Arm Description: Roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed. Receives: Drug: Roflumilast 500 Mcg Oral Tablet |
| Vitamin E group or control group (n=24) | Active comparator | vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed. Receives: Drug: Vitamin E capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver stiffness measurement (LSM) measured by fibroscan score
Liver Stiffness measurement (LSM) by fibro-scan. Transient elastography (Fibroscan, Echosens, Paris) was used to assess liver stiffness depending up-on the method formerly prescribed .Through a single independent operator, at least ten valid measurements were obtained for each patient. Results were included in the final analysis only if the following three criteria were met: at least ten valid measurements, success rate >60% and the interquartile range (IQR)-to-liver stiffness ratio was ≤0.30. The median values of the validated measurements for each patient were representative to the liver stiffness and expressed in units of kilopascals (kPa)
Measured: 12 weeks following the end of treatment
Secondary outcomes (2)
The change in liver panel parameters
Blood sample collection and biochemical measurement of Approximately 10 ml of venous blood was taken from each patient after overnight fasting by sterile venipuncture, without frothing and after minimal venous stasis using disposable syringes. Blood samples were delivered in a vacutainer serum separator tubes. Immediate centrifugation at 3000 rpm was performed and then the serum was separated and divided into two portions. The first portion was used for determination of fasting blood glucose (glucose oxidase method), liver enzymes aspartate transaminase "AST", alanine transaminase "ALT" and gamma-glutamyl transaminase "GGT" (spectrophotometerially) and lipid panel (enzymatic colorimeteric method).
Measured: 3 months after treatment
Improvement in HOMA IR
HOMA-IR is calculated as [Fasting Insulin (μg/ml)]*[Fasting Glucose (mmol/l)]/22.5,HOMA-IR values between 0.5 and 1.4 are considered normal, ≥1.9 are indicative of early IR, and ≥2.9 indicate IR
Measured: 12 weeks following the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Apr 2022
- Primary completion20 Sep 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Steatohepatitis (NASH)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a randomized controlled parallel study. Patients were recruited from out-patient clinic of Tropical medicine department, Tanta university hospital, Tanta, Egypt. The study involved 55 patients with NASH who were randomized using sealed envelope methods with assignment codes for each available allocation into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily. The study duration was 3 months whereas patients were assessed at baseline and 3 months after intervention. The study was conducted following the ethical standards of Helsinki declaration in 1964 and its later amendments. The study was approved by Research Ethical committee of Tanta University (approval code:35336/3/22).participants gave their written informed consent.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mokhtar Salem Mohamed, Tanta University
- Investigators
- Tarek Mohamed Mostafa, Professor of clinical pharmacy, Study chair, Faculty of Pharmacy , Tanta University, Tanta, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677788
- Sponsor's protocol ID
- 35336/3/22
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in non alcoholic steatohepatitis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Roflumilast in Patients with Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT06677788
- Acronym / sponsor ID
- 35336/3/22
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Keywords
- NASH, Roflumilast, LSM, TNF-α, MDA, TGF-ß1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 7 Nov 2024 (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.
Study type :clinical trial Main purpose :esnsure safety and efficacy of Roflumilast to treat patients with Non-Alcoholic Steatohepatitis Background and aim: Non-alcoholic fatty liver disease is the most prevalent chronic liver disease globally. There is no defined therapy for non-alcholic steatohepatitis (NASH), therefore this study aimed at evaluating the efficacy and safety of Roflumilast in patients with non-alcoholic NASH.
Methods: This randomized controlled parallel study involved 55 patients with NASH who were randomized into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily for three months.
Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of the homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was a randomized controlled parallel study. Patients were recruited from out-patient clinic of Tropical medicine department, Tanta university hospital, Tanta, Egypt. The study involved 55 patients with NASH who were randomized using sealed envelope methods with assignment codes for each available allocation into vitamin E group or control group (n=24) which received vitamin E 1000 mg once daily and roflumilast group (n=31) which received roflumilast 500 μg once daily. The study duration was 3 months whereas patients were assessed at baseline and 3 months after intervention. The study was conducted following the ethical standards of Helsinki declaration in 1964 and its later amendments. The study was approved by Research Ethical committee of Tanta University (approval code:35336/3/22).participants gave their written informed consent.
| Arm | Type | Receives |
|---|---|---|
| Roflumilast group (n=31) | Active comparator | Drug: Roflumilast 500 Mcg Oral TabletArm Description: Roflumilast group (n=31) which received roflumilast 500 μg once daily for three months. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed. |
| Vitamin E group or control group (n=24) | Active comparator | Drug: Vitamin E capsulevitamin E group or control group (n=24) which received vitamin E 1000 mg once daily. Patients were assessed at baseline and after intervention through liver stiffness measurement (LSM) using fibro-scan and through evaluation of serum levels of tumor necrosis factor -alpha (TNF-α), Malondialdehyde (MDA), transforming growth factor-beta 1 (TGF-ß1). In addition, liver enzymes, lipid panel, fasting blood glucose and fasting insulin level with subsequent calculation of homeostatic model assessment for Insulin resistance (HOMA-IR) were also assessed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Cytokeratine level >240 IU/L.
- Adult patient (age > 18 years old).
- Both sex.
- Overweight and obese.
- Patients with evidence of steatosis through imaging.
Key exclusion criteria (10 listed)
- Alcohol consumer and smokers
- Patients with Wilson's disease and hemochromatosis .
- Patients with viral hepatitis.
- Patients with cirrhosis .
- Patients with inflammatory diseases .
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 |
|---|---|---|
| Roflumilast 500 Mcg Oral TabletPatients in this group received roflumilast 500 μg once daily for three months. | Drug | Roflumilast group (n=31) |
| Vitamin E capsulevitamin E group or control group (n=24) which received vitamin E 1000 mg once daily | Drug | Vitamin E group or control group (n=24) |
Primary outcome
Change in liver stiffness measurement (LSM) measured by fibroscan score
Time frame: 12 weeks following the end of treatment
Liver Stiffness measurement (LSM) by fibro-scan. Transient elastography (Fibroscan, Echosens, Paris) was used to assess liver stiffness depending up-on the method formerly prescribed .Through a single independent operator, at least ten valid measurements were obtained for each patient. Results were included in the final analysis only if the following three criteria were met: at least ten valid measurements, success rate >60% and the interquartile range (IQR)-to-liver stiffness ratio was ≤0.30. The median values of the validated measurements for each patient were representative to the liver stiffness and expressed in units of kilopascals (kPa)
2 secondary outcomes
The change in liver panel parameters
Time frame: 3 months after treatment
Improvement in HOMA IR
Time frame: 12 weeks following the end of treatment
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 7 Nov 2024.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in non alcoholic steatohepatitis. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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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.
Tarek Mohamed Mostafa, Professor of clinical pharmacy study chair
Faculty of Pharmacy , Tanta University, Tanta, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Roflumilast 500 Mcg Oral Tablet and Vitamin E capsule in people with Non-Alcoholic Steatohepatitis (NASH), run by Tanta 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 9 inclusion and 10 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 7 Nov 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 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?
Change in liver stiffness measurement (LSM) measured by fibroscan score (time frame: 12 weeks following the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2024.