Comparison · NCT00457015-69bf014a
KALBITOR (Ecallantide) vs Placebo: Patients With Significant Improvement in Overall 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. KALBITOR (Ecallantide) vs Placebo: Patients With Significant Improvement in Overall Response. Trial comparisons, record NCT00457015-69bf014a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457015-69bf014a
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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 | 0.458 | 0.326 | 0.597 | wilson | |
| Risk in group 2 | 0.25 | 0.149 | 0.388 | wilson | |
| Risk difference, group 1 minus group 2 | 0.208 | 0.0171 | 0.38 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.83 | 1.03 | 3.27 | log | |
| Odds ratio, group 1 over group 2 | 2.54 | 1.07 | 6.03 | log | |
| Number needed to treat, for one more participant with the outcome on KALBITOR (Ecallantide) than on Placebo | 4.8 | 2.63 | 58.6 | 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. | 22 | 48 | OG000 |
| Group 2 | Placebo | Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections. | 12 | 48 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Patients With Significant Improvement in Overall Response
- Description
Patients were to be asked to perform an overall response assessment at intervals during the first 4 hours post-dose. Assessments were to be made relative to baseline (ie, immediately before initial dosing) using a 5-category scale. 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. Significant improvement is the first time that a patient responded to the overall response assessment as a lot better or resolved.
- Time frame
- 4 hours post-dose
- Population
The time to significant improvement is not provided in this display as the estimated median times were not reached by 240 minutes. Instead, the number of patients with significant improvement is provided per treatment arm.
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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