Effect of Alpha-1 Antitrypsin Supplementation in Alcohol-Associated Hepatitis-A prospective Pilot Study

Conditions

Alcohol-Associated Hepatitis

Brief summary

Serum concentration of IL-6 assessed at Visit 2 (Day 8+/-1) in the intervention (A1AT in combination with standard-of-care) and control group (standard-of-care).

Detailed description

The secondary endpoints are: (i) serum A1AT concentration assessed at visit 5 (Day 29+/-3); (ii) incidence of Adverse Events (AEs) from the baseline visit (Day 1) to end of study visit (Day 90+/-7); and (iii) incidence of Serious Adverse Events (SAEs) from the baseline visit (Day 1) through to end of study visit (Day 90+/-7). CLDQ-D overall and subscale scores., Exploratory endpoints: Clinical disease scores : CLDQ-D overall and subscale scores, MELD, MELD-Na, Child-Pugh-Turcotte, CLIF-C-AD, CLIF-C-OF, CLIF-SOFA score, Maddrey’s discriminant function. Clinical outcome: time to hospital discharge, time to re-hospitalization, time to ICU admission, liver-specific survival and transplant-free survival at End of Study Visit. Serum concentrations of IL-6

Related papers

No related papers found yet.

Interventions

DRUGPrednisolon "Nycomed“ 5 mg - Tabletten

DRUGProlastin 1000 mg

DRUGPulver und Lösungsmittel zur Her- stellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Serum concentration of IL-6 assessed at Visit 2 (Day 8+/-1) in the intervention (A1AT in combination with standard-of-care) and control group (standard-of-care).	—

Secondary

Measure	Time frame
The secondary endpoints are: (i) serum A1AT concentration assessed at visit 5 (Day 29+/-3); (ii) incidence of Adverse Events (AEs) from the baseline visit (Day 1) to end of study visit (Day 90+/-7); and (iii) incidence of Serious Adverse Events (SAEs) from the baseline visit (Day 1) through to end of study visit (Day 90+/-7). CLDQ-D overall and subscale scores., Exploratory endpoints: Clinical disease scores : CLDQ-D overall and subscale scores, MELD, MELD-Na, Child-Pugh-Turcotte, CLIF-C-AD, CLIF-C-OF, CLIF-SOFA score, Maddrey’s discriminant function. Clinical outcome: time to hospital discharge, time to re-hospitalization, time to ICU admission, liver-specific survival and transplant-free survival at End of Study Visit. Serum concentrations of IL-6	—

Measure

Time frame

The secondary endpoints are: (i) serum A1AT concentration assessed at visit 5 (Day 29+/-3); (ii) incidence of Adverse Events (AEs) from the baseline visit (Day 1) to end of study visit (Day 90+/-7); and (iii) incidence of Serious Adverse Events (SAEs) from the baseline visit (Day 1) through to end of study visit (Day 90+/-7). CLDQ-D overall and subscale scores., Exploratory endpoints: Clinical disease scores : CLDQ-D overall and subscale scores, MELD, MELD-Na, Child-Pugh-Turcotte, CLIF-C-AD, CLIF-C-OF, CLIF-SOFA score, Maddrey’s discriminant function. Clinical outcome: time to hospital discharge, time to re-hospitalization, time to ICU admission, liver-specific survival and transplant-free survival at End of Study Visit. Serum concentrations of IL-6

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Countries

Austria

Outcome results

None listed