Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650124
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Induction of Remission in Autoimmune Hepatitis with Azathioprine Vs MMF
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Induction of Remission in Autoimmune Hepatitis with Azathioprine Vs MMF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to determine the effectiveness of azathioprine AZA versus mycophenolate mofetil MMF in inducing remission in treatment-naive patients with autoimmune hepatitis AIH The main questions it aims to answer are
Does MMF combined with prednisolone lead to higher remission rates compared to AZA with prednisolone after 24 weeks Is MMF associated with fewer adverse events than AZA in these patients Researchers will compare two treatment arms MMF vs AZA to see if MMF leads to improved remission rates and safety outcomes
Primary Outcome Measure
Biochemical remission The primary outcome is the normalization of liver enzymes AST ALT and IgG levels at 24 weeks
Secondary Outcome Measures
Safety and adverse events Monitoring and comparing the incidence and severity of side effects between the two groups
Treatment adherence Evaluating how well patients stick to their assigned treatment regimens
Improvement in quality of life Assessing changes in the patients quality of life using validated questionnaires
Reversal of fibrosis Measured by liver stiffness using Fibroscan aiming for no progression of fibrosis
Participants will
Receive either MMF or AZA alongside a tapering dose of prednisolone Be monitored regularly through clinic visits laboratory tests and safety assessments to track remission and any adverse events
Does MMF combined with prednisolone lead to higher remission rates compared to AZA with prednisolone after 24 weeks Is MMF associated with fewer adverse events than AZA in these patients Researchers will compare two treatment arms MMF vs AZA to see if MMF leads to improved remission rates and safety outcomes
Primary Outcome Measure
Biochemical remission The primary outcome is the normalization of liver enzymes AST ALT and IgG levels at 24 weeks
Secondary Outcome Measures
Safety and adverse events Monitoring and comparing the incidence and severity of side effects between the two groups
Treatment adherence Evaluating how well patients stick to their assigned treatment regimens
Improvement in quality of life Assessing changes in the patients quality of life using validated questionnaires
Reversal of fibrosis Measured by liver stiffness using Fibroscan aiming for no progression of fibrosis
Participants will
Receive either MMF or AZA alongside a tapering dose of prednisolone Be monitored regularly through clinic visits laboratory tests and safety assessments to track remission and any adverse events
Detailed Description:
This clinical trial aims to compare the efficacy and safety of azathioprine AZA versus mycophenolate mofetil MMF in inducing remission in treatment-naive patients with autoimmune hepatitis AIH Autoimmune hepatitis is a chronic liver disease characterized by immune-mediated liver inflammation leading to liver damage cirrhosis or liver failure if untreated
The study will be conducted at the Institute of Liver and Biliary Sciences ILBS where eligible patients with AIH will be randomly assigned to one of two treatment groups
AZA Group Patients will receive azathioprine at an initial dose of 50 mgday increased to 100 mgday after two weeks combined with a tapering dose of prednisolone
MMF Group Patients will receive mycophenolate mofetil at an initial dose of 1000 mgday increased to 2000 mgday after two weeks along with a tapering dose of prednisolone
The trial will enroll 108 patients and follow a double-blind randomized controlled design The primary endpoint is achieving biochemical remission within 24 weeks defined by normalizing liver enzymes AST ALT and IgG levels Secondary endpoints include safety tolerability treatment adherence quality of life and the prevention or reversal of liver fibrosis as measured by Fibroscan
The trials expected duration is one year with follow-up visits every 4 weeks to monitor patient progress and adverse events All necessary tests and treatments will follow institutional protocols without additional cost to participants
This study is essential to address the current gaps in AIH treatment offering critical evidence to guide future clinical decisions on the use of MMF versus AZA for remission induction in AIH
The study will be conducted at the Institute of Liver and Biliary Sciences ILBS where eligible patients with AIH will be randomly assigned to one of two treatment groups
AZA Group Patients will receive azathioprine at an initial dose of 50 mgday increased to 100 mgday after two weeks combined with a tapering dose of prednisolone
MMF Group Patients will receive mycophenolate mofetil at an initial dose of 1000 mgday increased to 2000 mgday after two weeks along with a tapering dose of prednisolone
The trial will enroll 108 patients and follow a double-blind randomized controlled design The primary endpoint is achieving biochemical remission within 24 weeks defined by normalizing liver enzymes AST ALT and IgG levels Secondary endpoints include safety tolerability treatment adherence quality of life and the prevention or reversal of liver fibrosis as measured by Fibroscan
The trials expected duration is one year with follow-up visits every 4 weeks to monitor patient progress and adverse events All necessary tests and treatments will follow institutional protocols without additional cost to participants
This study is essential to address the current gaps in AIH treatment offering critical evidence to guide future clinical decisions on the use of MMF versus AZA for remission induction in AIH
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None