Trial · NCT01059526

Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema

NCT01059526, Completed, Shire; results first posted 2014-10-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema. Trials, record NCT01059526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01059526

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Trial

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

Title: Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
NCT number: NCT01059526
Status: Completed
Enrollment: 81 participants, actual
Lead sponsor: Shire
Conditions: Hereditary Angioedema (HAE)
Interventions: ecallantide
First posted: 2010-02-01
Last updated: 2021-06-08
Results first posted: 2014-10-06
Limitations and caveats: 44 patients (out of 200 planned) received treatment in this study. Additionally, the collection of evaluable efficacy data for the secondary endpoint was limited by a lack of response data collected for HAE attacks treated at alternate sites.

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity	12 months after first treatment	Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.
Primary	Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.	12 months after first treatment	Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies. Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered.
Primary	Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR	12 months after first treatment	Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.
Secondary	Overall Patient Response Assessment	within 4 hours post dose	The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as "a lot better or resolved," "a little better," "the same," "a little worse," or "a lot worse." The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of "a lot better or resolved" and "a little better" were combined to form a category of "Better." Similarly, "a little worse" and "a lot worse" were combined to form a category of "Worse." Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity	12 months after first treatment	Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR	participants	NUMBER
PRIMARY	Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.	12 months after first treatment	Based on total number of patients who were not positive for the antibody class at study entry and had at least one post-baseline antibody evaluation. N=40 evaluable patients for all immunoglobulin antibody classes; N=41 evaluable patients for IgE to ecallantide antibodies; N=41 evaluable patients for neutralizing antibodies to ecallantide.	participants	NUMBER
PRIMARY	Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR	12 months after first treatment		participants	NUMBER
SECONDARY	Overall Patient Response Assessment	within 4 hours post dose	Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR. Analysis only includes episodes of patients who were treated at the study site.	participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity	Safety Population	Type 1 hypersensitivity	4	95% Confidence Interval 0.6 to 17.6	participants
Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity	Safety Population	Anaphylaxis per NIAID criteria	2	95% Confidence Interval 0.0 to 10.7	participants
Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.	Safety Population	Seroconversion based on all Ig antibody classes	6	95% Confidence Interval 3.9 to 26.1	participants
Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.	Safety Population	Seroconversion based on IgE to ecallantide	0	95% Confidence Interval NA to NA	participants
Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.	Safety Population	Seroconversion based on neutralizing antibodies	5	95% Confidence Interval 2.2 to 22.2	participants
Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR	Safety Population		0	95% Confidence Interval NA to NA	participants
Overall Patient Response Assessment	Patients Naive to KALBITOR	Better	10		participants
Overall Patient Response Assessment	Patients Non- Naive to KALBITOR	Better	15		participants
Overall Patient Response Assessment	Patients Naive to KALBITOR	Same	1		participants
Overall Patient Response Assessment	Patients Non- Naive to KALBITOR	Same	2		participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Patients Naive to KALBITOR	41
Overall Study	STARTED	Patients Non- Naive to KALBITOR	40
Overall Study	Treated	Patients Naive to KALBITOR	21
Overall Study	Treated	Patients Non- Naive to KALBITOR	23
Overall Study	COMPLETED	Patients Naive to KALBITOR	11
Overall Study	COMPLETED	Patients Non- Naive to KALBITOR	18
Overall Study	NOT COMPLETED	Patients Naive to KALBITOR	30
Overall Study	NOT COMPLETED	Patients Non- Naive to KALBITOR	22

Source ClinicalTrials.gov

Adverse events12

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	Skin test positive	Investigations	Safety Population	5	44
other	Hereditary angioedema	Congenital, familial and genetic disorders	Safety Population	4	44
other	Abdominal pain upper	Gastrointestinal disorders	Safety Population	2	44
other	Nausea	Gastrointestinal disorders	Safety Population	2	44
other	Upper respiratory tract infection	Infections and infestations	Safety Population	2	44
other	Dehydration	Metabolism and nutrition disorders	Safety Population	2	44
other	Erythema	Skin and subcutaneous tissue disorders	Safety Population	2	44
serious	Dehydration	Metabolism and nutrition disorders	Safety Population	2	44
serious	Hereditary angioedema	Congenital, familial and genetic disorders	Safety Population	2	44
serious	Drug ineffective for unapproved indication	General disorders	Safety Population	1	44

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Safety Population
Total, other adverse events	Safety Population	14	44
Total, serious adverse events	Safety Population	6	44

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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.

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.

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GET https://conductscience.org/api/trials/v1/NCT01059526/registered

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