Salvage Therapy in Autoimmune Hepatitis
C
Craig Lammert, MD
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
1 Location
Brief description of study
What is the purpose of this study?
The purpose of the study is assess treatment outcomes in people who are taking rituximab as treatment for autoimmune hepatitis (AIH). The treatment itself is not part of the study.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Prospective participants will be identified at clinic visits for their provider, who is listed among the study investigators.
Detailed description of study
What will happen during the study?
The salvage therapy regimen will be administered as part of clinical treatment for AIH and is not the purpose of this research project. The study simply follows the clinical care of subjects who are taking this regimen and the data are recorded in a RedCap database.
Data points collected from both the participant and the medical records include: • laboratory values • medical history • medication history • imaging and biopsy results • side effects of the drug Additionally, approximately 20mL of blood will be drawn for future research purposes at five time points in three month intervals for the first year after rituximab initiation: • initial study visit, prior to initiation of the salvage therapy • 3 months post therapy • 6 months post therapy • 9 months post therapy • 12 months post therapy
Finally, liver stiffness and steatosis will be assessed in a noninvasive manner with transient elastography via FibroScan® at the initial study visit and the last study visit (12 months post therapy).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Autoimmune Hepatitis
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria
Initiation of rituximab as treatment for AIH
Updated on
17 Feb 2025.
Study ID: GI-IIR-AIH-SALVAGE, 1903230072
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