Comparison · NCT00457015-63f0036d
KALBITOR (Ecallantide) vs Placebo: Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. KALBITOR (Ecallantide) vs Placebo: Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours. Trial comparisons, record NCT00457015-63f0036d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457015-63f0036d
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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 | 0.438 | 0.307 | 0.577 | wilson | |
| Risk in group 2 | 0.213 | 0.12 | 0.349 | wilson | |
| Risk difference, group 1 minus group 2 | 0.225 | 0.0361 | 0.393 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.06 | 1.09 | 3.89 | log | |
| Odds ratio, group 1 over group 2 | 2.88 | 1.17 | 7.09 | log | |
| Number needed to treat, for one more participant with the outcome on KALBITOR (Ecallantide) than on Placebo | 4.45 | 2.55 | 27.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | KALBITOR (Ecallantide) | KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections. | 21 | 48 | OG000 |
| Group 2 | Placebo | Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. | 10 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours
- Description
Maintenance of significant improvement was defined as achieving and maintaining a significant improvement in overall response through 24 hours after dosing. Patient response categories were: significant improvement = a lot better or resolved; improvement = a little better; same = response unchanged; worsening = a little worse; significant worsening = a lot worse.
- Time frame
- 24 hours post-dosing
- Population
- Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
- NCT number
- NCT00457015
- Phases
- PHASE3
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- ecallantide, Phosphate Buffer Saline (PBS), pH 7.0
- Lead sponsor
- Shire
- Results first posted
- 2010-05-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00457015?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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