Trial · NCT00457015

Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

NCT00457015, Phase 3, Completed, Shire; results first posted 2010-05-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE). Trials, record NCT00457015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00457015

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
NCT number: NCT00457015
Status: Completed
Phases: Phase 3
Enrollment: 96 participants, actual
Lead sponsor: Shire
Conditions: Hereditary Angioedema (HAE)
Interventions: ecallantide, Phosphate Buffer Saline (PBS), pH 7.0
First posted: 2007-04-05
Last updated: 2021-06-08
Results first posted: 2010-05-04

Source ClinicalTrials.gov

Registered outcomes5

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 Hours Post-dose	baseline, 4 hours post-dose	The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, 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 at 4 Hours Post-Dose	4 hours post-dose	Treatment Outcome Score (TOS) is a validated, comprehensive measure of symptom response to treatment. At 4 hours , patient assessment of response characterized by their change from baseline in symptom severity and collected by anatomic site of attack involvement, was recorded on a categorical scale (significant improvement \[100; best value\]to significant worsening \[-100; worst value\]). Clinically meaningful improvement was indicated by a TOS of 30 or higher.
Secondary	Patients With Significant Improvement in Overall Response	4 hours post-dose	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."
Secondary	Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score	baseline, 4 hours post-dosing	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.
Secondary	Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours	24 hours post-dosing	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".

Source ClinicalTrials.gov

Outcomes5

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 Hours Post-dose	baseline, 4 hours post-dose	Patients were excluded from the analysis if they did not have data for the endpoint being analyzed. Reasons for patients being excluded are for ecallantide: 1 patient treated for severe upper airway compromise; for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data. Best score=0.0; worst score=3.0.	units on a scale	MEAN
SECONDARY	Treatment Outcome Score at 4 Hours Post-Dose	4 hours post-dose	Patients were excluded from this analysis if they did not have data for the endpoint being analyzed. The reasons for patients being excluded from this analysis are for ecallantide: 1 patient treated for severe upper airway compromise and for placebo: 3 patient treated for severe upper airway compromise and 3 patients with missing 4-hour data.	units on a scale	MEAN
SECONDARY	Patients With Significant Improvement in Overall Response	4 hours post-dose	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.	participants	NUMBER
SECONDARY	Patients With a Successful Response at 4 Hours Post-dosing, Based on the Change From Baseline in the MSCS Score	baseline, 4 hours post-dosing	Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.	participants	NUMBER
SECONDARY	Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours	24 hours post-dosing	Diary information was not available for 1 patient in the placebo arm. This patient was considered not evaluable and excluded from the analysis.	participants	NUMBER

Source ClinicalTrials.gov

Results by group14

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 Hours Post-dose	KALBITOR (Ecallantide)	MSCS Score at baseline	2.2	Standard Deviation 0.50	units on a scale
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	Placebo	MSCS Score at baseline	2.0	Standard Deviation 0.35	units on a scale
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	KALBITOR (Ecallantide)	MSCS Score at 4 hours post-dose	1.4	Standard Deviation 0.75	units on a scale
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	Placebo	MSCS Score at 4 hours post-dose	1.6	Standard Deviation 0.77	units on a scale
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	KALBITOR (Ecallantide)	Change from baseline in MSCS at 4 hours post-dose	-0.8	Standard Deviation 0.63	units on a scale
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose	Placebo	Change from baseline in MSCS at 4 hours post-dose	-0.4	Standard Deviation 0.82	units on a scale
Treatment Outcome Score at 4 Hours Post-Dose	KALBITOR (Ecallantide)		53.4	Standard Deviation 49.70	units on a scale
Treatment Outcome Score at 4 Hours Post-Dose	Placebo		8.1	Standard Deviation 63.18	units on a scale
Patients With Significant Improvement in Overall Response	KALBITOR (Ecallantide)		22		participants
Patients With Significant Improvement in Overall Response	Placebo		12		participants

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	KALBITOR (Ecallantide)	48
Overall Study	STARTED	Placebo	48
Overall Study	COMPLETED	KALBITOR (Ecallantide)	48
Overall Study	COMPLETED	Placebo	47
Overall Study	NOT COMPLETED	KALBITOR (Ecallantide)	0
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events10

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
other	Diarrhoea	Gastrointestinal disorders	KALBITOR (Ecallantide)	0	48
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	48
other	Headache	Nervous system disorders	KALBITOR (Ecallantide)	2	48
other	Headache	Nervous system disorders	Placebo	5	48
other	Nausea	Gastrointestinal disorders	KALBITOR (Ecallantide)	3	48
other	Nausea	Gastrointestinal disorders	Placebo	1	48
other	Vomiting	Gastrointestinal disorders	KALBITOR (Ecallantide)	0	48
other	Vomiting	Gastrointestinal disorders	Placebo	3	48
serious	Hereditary angioedema	Congenital, familial and genetic disorders	KALBITOR (Ecallantide)	0	48
serious	Hereditary angioedema	Congenital, familial and genetic disorders	Placebo	3	48

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	KALBITOR (Ecallantide)
Total, all-cause mortality	Placebo
Total, other adverse events	KALBITOR (Ecallantide)	5	48
Total, other adverse events	Placebo	9	48
Total, serious adverse events	KALBITOR (Ecallantide)	0	48
Total, serious adverse events	Placebo	3	48

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21130380	DERIVED	PubMed
22765833	DERIVED	PubMed
23548526	DERIVED	PubMed
23548529	DERIVED	PubMed
23878046	DERIVED	PubMed
24712435	DERIVED	PubMed

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 comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
KALBITOR (Ecallantide) vs Placebo: Proportion of Patients Maintaining a Significant Improvement in Overall Response Through 24 Hours	Trial comparisons
KALBITOR (Ecallantide) vs Placebo: Patients With Significant Improvement in Overall Response	Trial comparisons
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
KALBITOR (Ecallantide) vs Placebo: serious adverse events	Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00457015

GET https://conductscience.org/api/trials/v1/NCT00457015/registered

API reference For AI assistants