Comparison · NCT00289211-937a63b3
C1INH-nf vs Placebo: Number of Subjects With Beginning of Substantial Relief of the Defining Symptom
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. C1INH-nf vs Placebo: Number of Subjects With Beginning of Substantial Relief of the Defining Symptom. Trial comparisons, record NCT00289211-937a63b3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00289211-937a63b3
On this page
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 | 0.6 | 0.436 | 0.744 | wilson | |
| Risk in group 2 | 0.424 | 0.272 | 0.592 | wilson | |
| Risk difference, group 1 minus group 2 | 0.176 | -0.059 | 0.385 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.41 | 0.874 | 2.29 | log | |
| Odds ratio, group 1 over group 2 | 2.04 | 0.775 | 5.35 | log | |
| Number needed to treat, for one more participant with the outcome on C1INH-nf than on Placebo | 5.69 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | C1INH-nf | 1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered. | 21 | 35 | OG000 |
| Group 2 | Placebo | Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered. | 14 | 33 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Subjects With Beginning of Substantial Relief of the Defining Symptom
- Description
Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.
- Time frame
- Within 4 hours after initial treatment
- Population
ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized \[ie, ITT\] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema \[HAE\] attack).
Source ClinicalTrials.gov
Trial
- Title
- C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
- NCT number
- NCT00289211
- Phases
- PHASE3
- Conditions
- Hereditary Angioedema
- Interventions
- C1 esterase inhibitor [human] (C1INH-nf), Placebo (saline)
- Lead sponsor
- Shire
- Results first posted
- 2010-06-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00289211?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.govNone 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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00289211-937a63b3