Trial · NCT00456508
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
NCT00456508, Phase 3, Completed, Shire; results first posted 2012-12-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE). Trials, record NCT00456508. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00456508
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
- NCT number
- NCT00456508
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 147 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- ecallantide
- First posted
- 2007-04-05
- Last updated
- 2021-06-08
- Results first posted
- 2012-12-28
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | 4 hrs post dose after every episode | Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more. |
| Secondary | Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms | 4 hrs post dose after every episode | The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity. |
| Secondary | Time to Significant Improvement | 15 min - 4 hrs post dose after every episode | Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of "a lot better or resolved" in the overall response assessment. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | 4 hrs post dose after every episode | All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in MSCS score. | scores on a scale | MEAN |
| SECONDARY | Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms | 4 hrs post dose after every episode | All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score. | scores on a scale | MEAN |
| SECONDARY | Time to Significant Improvement | 15 min - 4 hrs post dose after every episode | All efficacy analyses were to be based on the safety population (all treated patients). Only those patients with non-missing severity and response assessment were included in the change in TOS score. | estimated time in minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 1 (n=138) | -1.04 | Standard Deviation 0.773 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 2 (n=98) | -1.06 | Standard Deviation 0.731 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 3 (n=73) | -1.07 | Standard Deviation 0.801 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 4 (n=52) | -1.15 | Standard Deviation 0.791 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 5 (n=38) | -1.16 | Standard Deviation 0.746 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 6 (n=32) | -1.07 | Standard Deviation 0.806 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 7 (n=25) | -1.24 | Standard Deviation 0.797 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 8 (n=22) | -1.31 | Standard Deviation 0.667 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 9 (n=22) | -1.20 | Standard Deviation 0.764 | scores on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing | DX-88 (Ecallantide) | change in MSCS at 4 hrs episode 10 (n=16) | -1.27 | Standard Deviation 1.027 | scores on a scale |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DX-88 (Ecallantide) | 147 | |
| Overall Study | COMPLETED | DX-88 (Ecallantide) | 147 | |
| Overall Study | NOT COMPLETED | DX-88 (Ecallantide) | 0 |
Source ClinicalTrials.gov
Adverse events31
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hereditary angioedema | Congenital, familial and genetic disorders | Treatment | 25 | 147 | 25 |
| other | nausea | Gastrointestinal disorders | Treatment | 19 | 147 | 19 |
| other | headache | Nervous system disorders | Treatment | 16 | 147 | 16 |
| other | abdominal pain | Gastrointestinal disorders | Treatment | 12 | 147 | 12 |
| other | upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | Treatment | 11 | 147 | 11 |
| other | vomiting | Gastrointestinal disorders | Treatment | 10 | 147 | 10 |
| other | diarrhoea | Gastrointestinal disorders | Treatment | 9 | 147 | 9 |
| other | anxiety | Psychiatric disorders | Treatment | 8 | 147 | 8 |
| serious | hereditary angioedema | Congenital, familial and genetic disorders | Treatment | 17 | 147 | 17 |
| serious | hypersensitivity | Immune system disorders | Treatment | 1 | 147 | 1 |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | ||
| Total, other adverse events | Treatment | 102 | 147 |
| Total, serious adverse events | Treatment | 27 | 147 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00456508
GET https://conductscience.org/api/trials/v1/NCT00456508/results?page=2