Metabolic Dysfunction-associated Fatty Liver DiseaseSMARTNCT06135584
Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
A study testing Pioglitazone metformin tablets, Other drugs and Drug-free in people with Metabolic Dysfunction-associated Fatty Liver Disease and Cirrhosis, run by The Affiliated Hospital of Hangzhou Normal University.
Trial summary
To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metabolic Dysfunction-associated Fatty Liver Disease, Cirrhosis
- What is being tested?
- Pioglitazone metformin tablets, Other drugs and Drug-free
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 18 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender and ethnicity are not limited;
- Meet the diagnostic criteria for MAFLD;
- F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
- Be willing to sign informed consent.
Who cannot join
- Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);
- Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
- According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).
- Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.
- Being tested
- Pioglitazone metformin tablets, Other drugs, Drug-free
- Keywords
- Treatment Strategies, Multicenter Real-World Study
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pioglitazone metformin tabletsDrug
Drug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study)
Other drugsDrug
Chinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1
Drug-freeOther
Drug-free
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone metformin tablets | Experimental | Pioglitazone metformin tablets 15mg/500mg (To control the fasting blood glucose below 7.0mmol/l, adjust the dose and dosage according to the blood glucose) Receives: Drug: Pioglitazone metformin tablets |
| Other drug | Active comparator | Chinese patent medicine or Hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin and GLP1 ((To control the fasting blood glucose below 7.0mmol/l) Receives: Drug: Other drugs |
| Drug-free | Other | Drug-free Receives: Other: Drug-free |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled attenuation parameter (CAP)
Measured: Through study completion, an average of 96 week.
Transient elastography
Measured: Through study completion, an average of 96 week.
Model for end-stage liver disease score
Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores)，higher scores mean a worse outcome
Measured: Through study completion, an average of 96 week.
Portalvein pressure gradient(HVPG)
Measured: Through study completion, an average of 96 week.
Prevalence of cirrhosis
Measured: Through study completion, an average of 96 week.
Prevalence of liver transplantation
Measured: Through study completion, an average of 96 week.
Prevalence of decompensated cirrhosis
Measured: Through study completion, an average of 96 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start18 Nov 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Fatty Liver DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135584
- Sponsor's protocol ID
- SMART
- Acronym
- SMART
- Status last verified
- Nov 2023
- First submitted
- 5 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies
- ClinicalTrials.gov ID
- NCT06135584
- Acronym / sponsor ID
- SMART / SMART
- Keywords
- Treatment Strategies, Multicenter Real-World Study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 18 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (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.
To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone metformin tablets | Experimental | Drug: Pioglitazone metformin tabletsPioglitazone metformin tablets 15mg/500mg (To control the fasting blood glucose below 7.0mmol/l, adjust the dose and dosage according to the blood glucose) |
| Other drug | Active comparator | Drug: Other drugsChinese patent medicine or Hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin and GLP1 ((To control the fasting blood glucose below 7.0mmol/l) |
| Drug-free | Other | Other: Drug-freeDrug-free |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years old, gender and ethnicity are not limited;
- Meet the diagnostic criteria for MAFLD;
- F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
- Be willing to sign informed consent.
Key exclusion criteria (4 listed)
- Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);
- Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
- According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).
- Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.
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 |
|---|---|---|
| Pioglitazone metformin tabletsDrug intervention for 24 weeks and follow-up for another 72 weeks (fasting blood glucose was controlled below 7.0mmol/l throughout the study) | Drug | Pioglitazone metformin tablets |
| Other drugsChinese patent medicine or hypoglycemic drugs other than pioglitazone metformin tablets, pioglitazone, metformin, GLP1 | Drug | Other drug |
| Drug-freeDrug-free | Other | Drug-free |
Primary outcome
Controlled attenuation parameter (CAP)
Time frame: Through study completion, an average of 96 week.
Transient elastography
Time frame: Through study completion, an average of 96 week.
Model for end-stage liver disease score
Time frame: Through study completion, an average of 96 week.
Model for end-stage liver disease score ranges from 6 to 40 score (>40 calculated as 40 scores)，higher scores mean a worse outcome
Portalvein pressure gradient(HVPG)
Time frame: Through study completion, an average of 96 week.
Prevalence of cirrhosis
Time frame: Through study completion, an average of 96 week.
Prevalence of liver transplantation
Time frame: Through study completion, an average of 96 week.
Prevalence of decompensated cirrhosis
Time frame: Through study completion, an average of 96 week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pioglitazone metformin tablets, Other drugs and Drug-free in people with Metabolic Dysfunction-associated Fatty Liver Disease and Cirrhosis, run by The Affiliated Hospital of Hangzhou Normal University.
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 4 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: opening soon, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junping Shi, Doctor (15869151180, 20181580@hznu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled attenuation parameter (CAP) (time frame: Through study completion, an average of 96 week.). The study lists 7 primary outcomes in all. 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 18 Nov 2023.