Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT03711669
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 1 AIH.
* AST/ALT within normal limits the 3 years prior inclusion.
* normal levels of IgG.
* \> 18 years-old.
Exclusion Criteria:
* Presence of biochemical alterations during the 3 years prior diagnosis.
* Coexistence of another autoimmune disease that requires IS.
* Prednisone doses over 7.5mg/day.
* Biopsy prior starting withdrawal with a Knodell score over 3/16.
* Positivity for hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
* Pregnancy.
* Glomerular filtrate \<35ml/min.
* Not being able to attend follow-up visits.
* Use of drugs or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03711669
Study Brief:
Protocol Section:
NCT03711669