Autoimmune HepatitisAIH DatabaseNCT06078098
Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
An observational study of Autoimmune Hepatitis and Liver Disorder, run by University of Milano Bicocca at 1 site in Italy.
Trial summary
Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Autoimmune Hepatitis, Liver Disorder
- What is being tested?
- Clinical Information
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 29 Mar 2023to 29 Mar 2034
- How long will I take part?
- 11 Years
- Phase
- Observational
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Italian AIH patients (diagnosis of AIH according to the most recent published guidelines EASL) aged at least 1 year
Who may be able to join
- All AIH patients living in Italy and aged at least 1 year can be included in the database.
- Willing and able to give informed consent prior to any study specific procedure being
- Diagnosis of AIH according to the most recent published guidelines (EASL)
Who cannot join
- Subject unwilling to participate at the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessio Gerussi, MD contact
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS San Gerardo dei Tintori
Monza, MB, 20900
Pietro Invernizzi, MD, pietro.invernizzi@unimib.it
Alessio Gerussi, MD, alessio.gerussi@unimib.it
About this study
Official title: Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown.
This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects > 1 years old in Italy.
Read the detailed description
Autoimmune Hepatitis (AIH) is a chronic fibroinflammatory disease of the liver characterized by chronic, relapsing inflammation, and a risk for progression to liver failure and development of hepatocellular cancer. Both children and adults are affected. A significant fraction of patients with AIH has a diminished life expectancy, despite treatment. Around 80% of patients respond to current therapies, but their quality of life and health is hugely impaired by side effects. The remaining proportion of patients (the difficult-to-treat category) do not respond to treatment and progress to liver cirrhosis and its complications; thus, timely identification of these individuals is a key aspect of epidemiological research in AIH.Taken together and combined with patients' debilitating quality of life issues, these data highlight the considerable disease burden and clinical impact of AIH on patients' outcomes.
Most epidemiological studies on AIH are retrospective case series based on tertiary referral series with relevant selection biases. Population-based studies, that include all cases in a defined geographical area, provide more accurate estimates of incidence, survival and mortality rate for the individual with AIH. Typically, multiple case-finding approaches have been used, including surveys, laboratory reports, liver histology databases, transplant registries, and death certificates. Only few population-based studies have been performed and limit the research population to a few dozen patients, reporting incidence rates ranging from 1.07 to 1.9 per 100,000 inhabitants. Reported point prevalence is 16.9 per 100,000.
To the investigators knowledge, there have been no epidemiologic studies in AIH carried out in Italy.
The investigators aim to develop a national registry on this rare disease to describe incidence and prevalence of AIH in Italy; identify and define distinct phenotypes and sub-phenotypes of AIH patients; identify factors influencing the progression of AIH and affecting mortality; assess safety and long-term efficacy of novel therapies.
This is a multicentre, nationwide, observational and prospective study based on the development of a patient's database linked to a biological sample storage. The enrollment period will cover 120 months to include the required number of patients. Based on litteraure, the estimated prevalence of AIH in Italy ranges from 6,000 to 15,000. Based on this, the investigators estimate to enroll approximately 10,000 patients. The minimum follow-up time will be 1 year.
- Conditions
- Autoimmune Hepatitis, Liver Disorder
- Being tested
- Clinical Information
- Keywords
- Autoimmune Hepatitis, National Database, Liver, Epidemiology
- Medical subject headings
- Hepatitis, Autoimmune, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical InformationOther
Also called Laboratory information, Biological samples
We will recruit AIH patients and collect important clinical information and laboratory investigation, together with biological samples.
| Study group | Role | What they receive |
|---|---|---|
| AIH patients | AIH population in Italy aged at least 1 year Receives: Other: Clinical Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 monthswithin 6 months
Measured: Overall duration of the study (11 years)
Number of participants with lack of biochemical response
Number of participants with lack of biochemical response
Measured: Overall duration of the study (11 years)
Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment
Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment
Measured: Overall duration of the study (11 years)
Number of participants with Hepatitis Activity Index <4/18
Number of participants with Hepatitis Activity Index <4/18
Measured: Overall duration of the study (11 years)
Intolerance to treatment
Any adverse event possibly related to treatment as assessed by the treating physician leading to potential discontinuation of the drug
Measured: Overall duration of the study (11 years)
Deep biochemical remissionof disease progression
ALT less than 50% ULN and IgG<12g/l
Measured: Overall duration of the study (11 years)
Relapse
An increase in serum ALT levels above three times the ULN and/or an increase in serum IgG levels to more than 20 g/l
Measured: Overall duration of the study (11 years)
Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks
Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks, with or without concomitant clinical symptoms and reinstitution of drug therapy after exclusion of other plausible causes for the elevated serum ALT
Measured: Overall duration of the study (11 years)
Number of participants with variceal bleeding requiring hospital admission
Number of participants with variceal bleeding requiring hospital admission
Measured: Overall duration of the study (11 years)
Number of participants with first evidence of ascites requiring hospital admission
Number of participants with first evidence of ascites requiring hospital admission
Measured: Overall duration of the study (11 years)
Number of participants with hepatic encephalopathy requiring hospital admission
Number of participants with hepatic encephalopathy requiring hospital admission
Measured: Overall duration of the study (11 years)
Number of participants with serum bilirubin levels > 1.0 mg/dl on more than one consecutive sample
Number of participants with serum bilirubin levels > 1.0 mg/dl on more than one consecutive sample
Measured: Overall duration of the study (11 years)
Number of participants with platelet count < 150.000/mm3 on more than one consecutive sample
Number of participants with platelet count < 150.000/mm3 on more than one consecutive sample
Measured: Overall duration of the study (11 years)
Number of participants with albumin levels < 3.5 mg/dL on more than one consecutive sample
Number of participants with albumin levels < 3.5 mg/dL on more than one consecutive sample
Measured: Overall duration of the study (11 years)
Secondary outcomes (3)
Liver stiffness
Liver stiffness by fibroscan
Measured: Overall duration of the study (11 years)
Number of participants achieving HAI score < 4 at follow-up biopsies
Number of participants achieving HAI score < 4 at follow-up biopsies
Measured: Overall duration of the study (11 years)
The time from the diagnosis of AIH to an event
Date of diagnosis of AIH: Defined as the date of the diagnostic liver biopsy, or the date of the first abnormal AST or ALT, or the date of starting therapy in those cases that did not perform a liver biopsy at baseline but fulfilled diagnostic criteria for the disease. Events: Defined as follows: (1) death from a liver-related cause, meaning liver failure, variceal hemorrhage, or HCC; (2) Liver Transplantation for AIH
Measured: Overall duration of the study (11 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start29 Mar 2023
- Primary completion29 Mar 2034 (estimated)
- Study completion29 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 11 Years
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078098
- Sponsor's protocol ID
- AIH Database
- Acronym
- AIH Database
- Status last verified
- Oct 2023
- First submitted
- 31 Mar 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heneghan MA, Yeoman AD, Verma S, Smith AD, Longhi MS. Autoimmune hepatitis. Lancet. 2013 Oct 26;382(9902):1433-44. doi: 10.1016/S0140-6736(12)62163-1. Epub 2013 Jun 14.
PubMed 23768844Sharma R, Verna EC, Soderling J, Roelstraete B, Hagstrom H, Ludvigsson JF. Increased Mortality Risk in Autoimmune Hepatitis: A Nationwide Population-Based Cohort Study With Histopathology. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2636-2647.e13. doi: 10.1016/j.cgh.2020.10.006. Epub 2020 Oct 14.
PubMed 33065308Mack CL, Adams D, Assis DN, Kerkar N, Manns MP, Mayo MJ, Vierling JM, Alsawas M, Murad MH, Czaja AJ. Diagnosis and Management of Autoimmune Hepatitis in Adults and Children: 2019 Practice Guidance and Guidelines From the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722. doi: 10.1002/hep.31065. Epub 2020 May 12. No abstract available.
PubMed 31863477Wong LL, Fisher HF, Stocken DD, Rice S, Khanna A, Heneghan MA, Oo YH, Mells G, Kendrick S, Dyson JK, Jones DEJ; UK-AIH Consortium. The Impact of Autoimmune Hepatitis and Its Treatment on Health Utility. Hepatology. 2018 Oct;68(4):1487-1497. doi: 10.1002/hep.30031.
PubMed 29663477Pape S, Snijders RJALM, Gevers TJG, Chazouilleres O, Dalekos GN, Hirschfield GM, Lenzi M, Trauner M, Manns MP, Vierling JM, Montano-Loza AJ, Lohse AW, Schramm C, Drenth JPH, Heneghan MA; International Autoimmune Hepatitis Group (IAIHG) collaborators(double dagger). Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group. J Hepatol. 2022 Apr;76(4):841-849. doi: 10.1016/j.jhep.2021.12.041. Epub 2022 Jan 20.
PubMed 35066089Heneghan MA, Shumbayawonda E, Dennis A, Ahmed RZ, Rahim MN, Ney M, Smith L, Kelly M, Banerjee R, Culver EL. Quantitative magnetic resonance imaging to aid clinical decision making in autoimmune hepatitis. EClinicalMedicine. 2022 Mar 21;46:101325. doi: 10.1016/j.eclinm.2022.101325. eCollection 2022 Apr.
PubMed 35340625van Gerven NM, Verwer BJ, Witte BI, van Hoek B, Coenraad MJ, van Erpecum KJ, Beuers U, van Buuren HR, de Man RA, Drenth JP, den Ouden JW, Verdonk RC, Koek GH, Brouwer JT, Guichelaar MM, Mulder CJ, van Nieuwkerk KM, Bouma G; Dutch Autoimmune Hepatitis Working Group. Relapse is almost universal after withdrawal of immunosuppressive medication in patients with autoimmune hepatitis in remission. J Hepatol. 2013 Jan;58(1):141-7. doi: 10.1016/j.jhep.2012.09.009. Epub 2012 Sep 16.
PubMed 22989569
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Autoimmune Hepatitis Patient's Database Linked to a Biological Sample Storage
- ClinicalTrials.gov ID
- NCT06078098
- Acronym / sponsor ID
- AIH Database / AIH Database
- Conditions
- Autoimmune Hepatitis, Liver Disorder
- Keywords
- Autoimmune Hepatitis, National Database, Liver, Epidemiology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 29 Mar 2034 (estimated)
- Study completion
- 29 Mar 2034 (estimated)
- First posted
- 11 Oct 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.
Autoimmune Hepatitis (AIH) is chronic fibroinflammatory disease of the liver characterized by chronic, relapsing liver inflammation, and a risk for progression to liver failure and need for liver transplantation. No AIH-specific registry does exist in Italy, so that the actual epidemiology of the disease in the country is unknown.
This is an observational, retrospective and prospective, multicenter study evaluating incidence, prevalence and disease course of AIH in subjects > 1 years old in Italy.
Detailed description
Autoimmune Hepatitis (AIH) is a chronic fibroinflammatory disease of the liver characterized by chronic, relapsing inflammation, and a risk for progression to liver failure and development of hepatocellular cancer. Both children and adults are affected. A significant fraction of patients with AIH has a diminished life expectancy, despite treatment. Around 80% of patients respond to current therapies, but their quality of life and health is hugely impaired by side effects. The remaining proportion of patients (the difficult-to-treat category) do not respond to treatment and progress to liver cirrhosis and its complications; thus, timely identification of these individuals is a key aspect of epidemiological research in AIH.Taken together and combined with patients' debilitating quality of life issues, these data highlight the considerable disease burden and clinical impact of AIH on patients' outcomes.
Most epidemiological studies on AIH are retrospective case series based on tertiary referral series with relevant selection biases. Population-based studies, that include all cases in a defined geographical area, provide more accurate estimates of incidence, survival and mortality rate for the individual with AIH. Typically, multiple case-finding approaches have been used, including surveys, laboratory reports, liver histology databases, transplant registries, and death certificates. Only few population-based studies have been performed and limit the research population to a few dozen patients, reporting incidence rates ranging from 1.07 to 1.9 per 100,000 inhabitants. Reported point prevalence is 16.9 per 100,000.
To the investigators knowledge, there have been no epidemiologic studies in AIH carried out in Italy.
The investigators aim to develop a national registry on this rare disease to describe incidence and prevalence of AIH in Italy; identify and define distinct phenotypes and sub-phenotypes of AIH patients; identify factors influencing the progression of AIH and affecting mortality; assess safety and long-term efficacy of novel therapies.
This is a multicentre, nationwide, observational and prospective study based on the development of a patient's database linked to a biological sample storage. The enrollment period will cover 120 months to include the required number of patients. Based on litteraure, the estimated prevalence of AIH in Italy ranges from 6,000 to 15,000. Based on this, the investigators estimate to enroll approximately 10,000 patients. The minimum follow-up time will be 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 11 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AIH patients | – | Other: Clinical InformationAIH population in Italy aged at least 1 year |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Italian AIH patients (diagnosis of AIH according to the most recent published guidelines EASL) aged at least 1 year
Key inclusion criteria (3 listed)
- All AIH patients living in Italy and aged at least 1 year can be included in the database.
- Willing and able to give informed consent prior to any study specific procedure being
- Diagnosis of AIH according to the most recent published guidelines (EASL)
Key exclusion criteria (1 listed)
- Subject unwilling to participate at the study
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 |
|---|---|---|
| Clinical InformationAlso: Laboratory information, Biological samplesWe will recruit AIH patients and collect important clinical information and laboratory investigation, together with biological samples. | Other | AIH patients |
Primary outcome
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months
Time frame: Overall duration of the study (11 years)
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 monthswithin 6 months
Number of participants with lack of biochemical response
Time frame: Overall duration of the study (11 years)
Number of participants with lack of biochemical response
Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment
Time frame: Overall duration of the study (11 years)
Number of participants with <50% decrease of AST and ALT within 4 weeks after initiation of treatment
Number of participants with Hepatitis Activity Index <4/18
Time frame: Overall duration of the study (11 years)
Number of participants with Hepatitis Activity Index <4/18
Intolerance to treatment
Time frame: Overall duration of the study (11 years)
Any adverse event possibly related to treatment as assessed by the treating physician leading to potential discontinuation of the drug
Deep biochemical remissionof disease progression
Time frame: Overall duration of the study (11 years)
ALT less than 50% ULN and IgG<12g/l
Relapse
Time frame: Overall duration of the study (11 years)
An increase in serum ALT levels above three times the ULN and/or an increase in serum IgG levels to more than 20 g/l
Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks
Time frame: Overall duration of the study (11 years)
Number of participants with An increase in serum ALT levels above ULN on at least two occasions with an interval of 4 weeks, with or without concomitant clinical symptoms and reinstitution of drug therapy after exclusion of other plausible causes for the elevated serum ALT
Number of participants with variceal bleeding requiring hospital admission
Time frame: Overall duration of the study (11 years)
Number of participants with variceal bleeding requiring hospital admission
Number of participants with first evidence of ascites requiring hospital admission
Time frame: Overall duration of the study (11 years)
Number of participants with first evidence of ascites requiring hospital admission
Number of participants with hepatic encephalopathy requiring hospital admission
Time frame: Overall duration of the study (11 years)
Number of participants with hepatic encephalopathy requiring hospital admission
Number of participants with serum bilirubin levels > 1.0 mg/dl on more than one consecutive sample
Time frame: Overall duration of the study (11 years)
Number of participants with serum bilirubin levels > 1.0 mg/dl on more than one consecutive sample
Number of participants with platelet count < 150.000/mm3 on more than one consecutive sample
Time frame: Overall duration of the study (11 years)
Number of participants with platelet count < 150.000/mm3 on more than one consecutive sample
Number of participants with albumin levels < 3.5 mg/dL on more than one consecutive sample
Time frame: Overall duration of the study (11 years)
Number of participants with albumin levels < 3.5 mg/dL on more than one consecutive sample
3 secondary outcomes
Liver stiffness
Time frame: Overall duration of the study (11 years)
Number of participants achieving HAI score < 4 at follow-up biopsies
Time frame: Overall duration of the study (11 years)
The time from the diagnosis of AIH to an event
Time frame: Overall duration of the study (11 years)
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 11 Oct 2023.
- Background: PubMed 23768844Heneghan MA, Yeoman AD, Verma S, Smith AD, Longhi MS. Autoimmune hepatitis. Lancet. 2013 Oct 26;382(9902):1433-44. doi: 10.1016/S0140-6736(12)62163-1. Epub 2013 Jun 14.
- Background: PubMed 33065308Sharma R, Verna EC, Soderling J, Roelstraete B, Hagstrom H, Ludvigsson JF. Increased Mortality Risk in Autoimmune Hepatitis: A Nationwide Population-Based Cohort Study With Histopathology. Clin Gastroenterol Hepatol. 2021 Dec;19(12):2636-2647.e13. doi: 10.1016/j.cgh.2020.10.006. Epub 2020 Oct 14.
- Background: PubMed 31863477Mack CL, Adams D, Assis DN, Kerkar N, Manns MP, Mayo MJ, Vierling JM, Alsawas M, Murad MH, Czaja AJ. Diagnosis and Management of Autoimmune Hepatitis in Adults and Children: 2019 Practice Guidance and Guidelines From the American Association for the Study of Liver Diseases. Hepatology. 2020 Aug;72(2):671-722. doi: 10.1002/hep.31065. Epub 2020 May 12. No abstract available.
- Background: PubMed 29663477Wong LL, Fisher HF, Stocken DD, Rice S, Khanna A, Heneghan MA, Oo YH, Mells G, Kendrick S, Dyson JK, Jones DEJ; UK-AIH Consortium. The Impact of Autoimmune Hepatitis and Its Treatment on Health Utility. Hepatology. 2018 Oct;68(4):1487-1497. doi: 10.1002/hep.30031.
- Background: PubMed 35066089Pape S, Snijders RJALM, Gevers TJG, Chazouilleres O, Dalekos GN, Hirschfield GM, Lenzi M, Trauner M, Manns MP, Vierling JM, Montano-Loza AJ, Lohse AW, Schramm C, Drenth JPH, Heneghan MA; International Autoimmune Hepatitis Group (IAIHG) collaborators(double dagger). Systematic review of response criteria and endpoints in autoimmune hepatitis by the International Autoimmune Hepatitis Group. J Hepatol. 2022 Apr;76(4):841-849. doi: 10.1016/j.jhep.2021.12.041. Epub 2022 Jan 20.
- Background: PubMed 35340625Heneghan MA, Shumbayawonda E, Dennis A, Ahmed RZ, Rahim MN, Ney M, Smith L, Kelly M, Banerjee R, Culver EL. Quantitative magnetic resonance imaging to aid clinical decision making in autoimmune hepatitis. EClinicalMedicine. 2022 Mar 21;46:101325. doi: 10.1016/j.eclinm.2022.101325. eCollection 2022 Apr.
- Background: PubMed 22989569van Gerven NM, Verwer BJ, Witte BI, van Hoek B, Coenraad MJ, van Erpecum KJ, Beuers U, van Buuren HR, de Man RA, Drenth JP, den Ouden JW, Verdonk RC, Koek GH, Brouwer JT, Guichelaar MM, Mulder CJ, van Nieuwkerk KM, Bouma G; Dutch Autoimmune Hepatitis Working Group. Relapse is almost universal after withdrawal of immunosuppressive medication in patients with autoimmune hepatitis in remission. J Hepatol. 2013 Jan;58(1):141-7. doi: 10.1016/j.jhep.2012.09.009. Epub 2012 Sep 16.
- 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.
Alessio Gerussi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis and Liver Disorder, run by University of Milano Bicocca at 1 site in Italy.
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 3 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: looking for participants now, as of the sponsor's last update on 11 Oct 2023. 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 Italy. 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.
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 Pietro Invernizzi, MD (039 233 2187, pietro.invernizzi@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Normalization of AST and ALT <1 x upper limit of normal (ULN)) and normal IgG levels within 6 months (time frame: Overall duration of the study (11 years)). The study lists 14 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 NCT06078098, which also lists 7 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 11 Oct 2023.