Comparison · NCT02282527-e6dc5292
Liquid Alpha₁-PI/Prolastin-C vs Prolastin-C/Liquid Alpha₁-PI: Number of Subjects With Immunogenicity Response
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. Liquid Alpha₁-PI/Prolastin-C vs Prolastin-C/Liquid Alpha₁-PI: Number of Subjects With Immunogenicity Response. Trial comparisons, record NCT02282527-e6dc5292. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02282527-e6dc5292
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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 | 0 | 0.194 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.194 | 0.194 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Liquid Alpha₁-PI/Prolastin-C | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions | 0 | 16 | OG000 |
| Group 2 | Prolastin-C/Liquid Alpha₁-PI | Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions | 0 | 16 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Immunogenicity Response
- Description
Blood samples for immunogenicity testing were collected at Weeks 1 (Baseline), 9, 17, and 20. Any samples that tested positive for alpha₁-PI antibodies were tested for neutralizing antibodies and antibody titer. Immunogenicity testing was performed using validated assays in a multitiered approach. Samples collected at Week 1 (Baseline) and at Weeks 9 and 20 were tested for immunogenicity while samples collected at Week 17 were to be tested for immunogenicity only if deemed appropriate (eg, unexpected PK profile).
- Time frame
- Weeks 1, 9, 17, and 20
- Population
Source ClinicalTrials.gov
Trial
- Title
- A Study to Assess Safety and PK of Liquid Alpha₁-Proteinase Inhibitor (Human) in Treating Alpha₁-Antitrypsin Deficiency
- NCT number
- NCT02282527
- Phases
- PHASE2, PHASE3
- Conditions
- Alpha₁-Antitrypsin Deficiency
- Interventions
- Liquid Alpha₁-PI, Prolastin-C
- Lead sponsor
- Grifols Therapeutics LLC
- Results first posted
- 2017-03-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02282527?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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