Comparison · NCT04072822-sae
Prednisone vs Anakinra and Zinc: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Prednisone vs Anakinra and Zinc: serious adverse events. Trial comparisons, record NCT04072822-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04072822-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.562 | 0.448 | 0.67 | wilson | |
| Risk in group 2 | 0.662 | 0.549 | 0.76 | wilson | |
| Risk difference, group 1 minus group 2 | -0.101 | -0.25 | 0.056 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.848 | 0.654 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.654 | 0.335 | 1.27 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Prednisone than on Anakinra and Zinc | 9.95 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Prednisone | Standard of care plus prednisone 40 mg orally once daily on Days 1-30 and matching placebos for Anakinra (1 syringe s.c. once daily on Days 1-14), and zinc (matched pill once daily on Days 1-90).~Prednisone: Prednisone is indicated for numerous conditions including inflammatory disease.~Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease. | 41 | 73 | EG000 |
| Group 2 | Anakinra and Zinc | Standard of care plus Anakinra (100 mg s.c.) once daily on Days 1-14 zinc sulfate 220 mg once daily on Days 1-90, and placebo for prednisone (matched pill once daily on Days 1-30).~Anakinra and Zinc: Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease. | 49 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 6 months
Source ClinicalTrials.gov
Trial
- Title
- Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
- NCT number
- NCT04072822
- Phases
- PHASE2
- Conditions
- Alcoholic Hepatitis
- Interventions
- Anakinra and Zinc, Prednisone, Placebos
- Lead sponsor
- Indiana University
- Results first posted
- 2023-07-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04072822?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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