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:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT06855667
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-60 years
2. Acute severe autoimmune hepatitis with MELD \>24
3. No liver transplant option \< 28 days.
4. -ACLF + Non ACLF
5. Auto immune hepatitis: Diagnosis by simplified AIH score ≥6
Exclusion Criteria:
1. Patients with Active sepsis
2. Patients with Active bleeding
3. Patients allergic to FFP and blood products
4. Patients with unstable hemodynamics ( eg:BP\<90/60 mmhg,HR \>100bpm)
5. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis
6. Pregnancy related liver failure
7. Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease)
8. Refusal to participate in the study
9. Patients who are eligible to transplant
10. Patients who received steroids or on steroids last 7 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06855667
Study Brief:
Protocol Section:
NCT06855667