Comparison · NCT00457015-d44364c9
KALBITOR (Ecallantide) vs Placebo: Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score
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. KALBITOR (Ecallantide) vs Placebo: Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score. Trial comparisons, record NCT00457015-d44364c9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457015-d44364c9
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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 | 0.938 | 0.832 | 0.979 | wilson | |
| Risk in group 2 | 0.596 | 0.453 | 0.724 | wilson | |
| Risk difference, group 1 minus group 2 | 0.342 | 0.176 | 0.49 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.57 | 1.23 | 2.01 | log | |
| Odds ratio, group 1 over group 2 | 10.2 | 2.76 | 37.6 | log | |
| Number needed to treat, for one more participant with the outcome on KALBITOR (Ecallantide) than on Placebo | 2.93 | 2.04 | 5.69 | 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. | 45 | 48 | OG000 |
| Group 2 | Placebo | Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. | 28 | 47 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score
- Description
A successful response was defined as improvement in existing laryngeal symptom complex,stabilization of an existing peripheral symptom complex, or a change from baseline in the MSCS score at 4 hours of at least -1.0.
- Time frame
- baseline, 4 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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