Ignite Creation Date:
2024-05-06 @ 3:57 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04810156
Status:
RECRUITING
Last Update Posted:
2022-12-14
First Post:
2021-03-17
Brief Title:
Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis
Sponsor:
Inge Marie Svane
Organization:
Herlev Hospital
Study Overview
Official Title:
A National Prospective Study of Patients With Hepatitis Induced by Immune Checkpoint Inhibitors Characterization of Liver Injury Outcome of Therapy and Randomization to Either Prednisolone or Mycophenolate Mofetil Treatment in Case of Relapse
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
I-HEP
Brief Summary:
This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent The project aims to prospectively characterize the various histopathological biochemical and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids Furthermore the effect of adding a second-line immunosuppressive drug either MMF in steroid-refractory or steroid-dependent cases will be explored and compared
Detailed Description:
The number of patients treated with immune checkpoint inhibitors ICI is expanding worldwide due to an increasing number of indications including additional types of cancer combination of ICI with other antineoplastic therapies and have recently moved into the adjuvant setting According to clinical trial material almost all patients in ICI treatment will eventually develop any grade of an adverse event here estimated in up to 90 percent of treated patients Around 10-30 percent of ICI-treated patients will show signs of liver injury related to ICI treatment and will be diagnosed with immune-related hepatitis The treatment hereof should include observation and medium-dose steroids in low-grade asymptomatic patients grade 2 ir-hepatitis and high-dose steroids in higher grades according to the current European and American guidelines However up to 25 percent of patients with ir-hepatitis may not respond properly to steroids due to primary resistance or relapse during tapering These patients should be offered a second-line immunosuppressive treatment The present recommendation for patients with steroid-dependent ir-hepatitis is based on the case series and includes immunosuppressive treatment with mycophenolate mofetil MMF To date no evidence exists for which second-line treatment to choose
However in the clinic the initiation of MMF may be delayed meanwhile patients are typically treated with an increased dose of steroids In some cases an increased dose of steroids with prolonged tapering can be sufficient We want to explore if increased doses of steroids or adding MMF is the best strategy for relapse of hepatitis
In addition patients with signs of biliary or mixed liver injury may benefit from adding ursodeoxycholic acid UDCA
However in the clinic the initiation of MMF may be delayed meanwhile patients are typically treated with an increased dose of steroids In some cases an increased dose of steroids with prolonged tapering can be sufficient We want to explore if increased doses of steroids or adding MMF is the best strategy for relapse of hepatitis
In addition patients with signs of biliary or mixed liver injury may benefit from adding ursodeoxycholic acid UDCA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None