Trial · NCT00262080
Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
NCT00262080, Phase 3, Completed, Shire; results first posted 2010-05-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE). Trials, record NCT00262080. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00262080
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
- NCT number
- NCT00262080
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 91 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- ecallantide, Phosphate Buffer Saline (PBS),
- First posted
- 2005-12-06
- Last updated
- 2021-06-11
- Results first posted
- 2010-05-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Outcome Score at 4 Hours Post-Dose | 4 hours post-dose (DOUBLE-BLIND PART) | 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 \[100\] to significant worsening \[-100\]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher. |
| Secondary | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | baseline, 4 hours post-dose (DOUBLE-BLIND PART) | 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 (minimally important difference) was indicated by a reduction in the score of 0.30 or more. |
| Secondary | Time to Significant Improvement in Overall Response | 4 hours post-dose (DOUBLE-BLIND PART) | The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline. Patients were asked "overall how are you feeling" compared to how they felt before study drug. Answer options were "a lot worse", "a little worse", "same", "a little better" or "a lot better or resolved". Significant improvement was the first time that the patient responded to the assessment as "a little better or resolved". |
| Other | Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART) | Baseline | Patient-reported severity of symptom complexes at baseline, by symptom complex and treatment group. Patients were to have at least one symptom complex that was moderate or severe. Patients could present with multiple symptom complexes, some of which could be mild. Mild=noticeable but do not impact daily living activities; Moderate=treatment or intervention is highly desirable and activities of daily living are impacted; Severe=require treatment or intervention due to inability to perform activities of daily living. The results are for number of patients with symptom complexes including mild, moderate and severe, provided the patients have at least one symptom complex that was moderate or severe |
| Other | Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes | 4 hours post-dose (REPEAT-DOSING PART) | 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 \[100\] to significant worsening \[-100\]). The response at each anatomic site was weighted by baseline severity and then the weighted scores across all involved sites were averaged to calculate the TOS. Clinically meaningful improvement was indicated by a TOS of 30 or higher. |
| Other | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes | baseline, 4 hours post-dose (REPEAT-DOSING PART) | 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. |
| Other | Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes | 4 hours post-dose (REPEAT-DOSING PART) | The overall response assessment is a patient-reported assessment of global response to therapy. Patients are asked to perform an overall response assessment at regular intervals, relative to baseline (ie,immediately before treatment) using the following 5-category scale from significant improvement (Score = 100)to significant worsening (Score = -100) |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Outcome Score at 4 Hours Post-Dose | 4 hours post-dose (DOUBLE-BLIND PART) | ITT as treated: two patients randomized on the same day at the same study center were administered treatment opposite to their randomized treatment assignment. Data were analyzed based on actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 100; worst possible score = -100. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | baseline, 4 hours post-dose (DOUBLE-BLIND PART) | ITT as treated: two patients randomized on the same day at the same center were administered treatment opposite to their randomized treatment assignments. Data were analyzed based on their actual treatment received. Imputation was used to account for emerging symptoms and medical intervention. Best possible score = 0.0; worst possible score = 3.0. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART) | Baseline | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Treatment Outcome Score at 4 Hours Post-Dose Over Multiple Treatment Episodes | 4 hours post-dose (REPEAT-DOSING PART) | Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention. | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose Over Multiple Treatment Episodes | baseline, 4 hours post-dose (REPEAT-DOSING PART) | Treatment episode 1 contains data only from those participants who were new patients in the repeat-dosing part. Treatment episode 2 and beyond contain data pooled from patients treated in the double-blind part (ecallantide or placebo) and the repeat-dosing part. Data imputation was used to account for emerging symptoms and medical intervention. | units on a scale | MEAN |
| SECONDARY | Time to Significant Improvement in Overall Response | 4 hours post-dose (DOUBLE-BLIND PART) | ITT as treated. Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the median time for placebo was not reached by 4 hours. | participant | NUMBER |
| OTHER_PRE_SPECIFIED | Time to Significant Improvement in Overall Response Over Multiple Treatment Episodes | 4 hours post-dose (REPEAT-DOSING PART) | Patients not reporting significant improvement before 4 hours were censored at 4 hours. Patients receiving additional HAE therapy within 4 hours were censored at the time of the medical intervention. The time to significant improvement is not provided in this display as the interquartile range (IQR) was not reached by 4 hours for most episodes. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Outcome Score at 4 Hours Post-Dose | Ecallantide | 49.5 | Standard Deviation 59.43 | units on a scale | |
| Treatment Outcome Score at 4 Hours Post-Dose | Placebo | 18.5 | Standard Deviation 67.78 | units on a scale | |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | Ecallantide | MSCS Score at baseline | 2.17 | Standard Deviation 0.51 | units on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | Placebo | MSCS Score at baseline | 2.24 | Standard Deviation 0.55 | units on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | Ecallantide | MSCS Score at 4 hours post-dose | 1.26 | Standard Deviation 0.96 | 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 | 1.75 | Standard Deviation 0.90 | units on a scale |
| Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose | Ecallantide | Change from baseline in MSCS at 4 hours post-dose | -0.91 | Standard Deviation 1.10 | 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 | -0.48 | Standard Deviation 0.68 | units on a scale |
| Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART) | Ecallantide | Internal Head/Neck Symptoms | 9 | participants | |
| Number of Patients With Symptom Complexes of Treated Attack at Baseline(DOUBLE-BLIND PART) | Placebo | Internal Head/Neck Symptoms | 4 | participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double Blind Treatment Period | STARTED | Ecallantide / Ecallantide | 36 | |
| Double Blind Treatment Period | STARTED | Placebo / Ecallantide | 36 | |
| Double Blind Treatment Period | STARTED | Ecallantide (Repeat Dose Only) | 0 | |
| Double Blind Treatment Period | COMPLETED | Ecallantide / Ecallantide | 35 | |
| Double Blind Treatment Period | COMPLETED | Placebo / Ecallantide | 36 | |
| Double Blind Treatment Period | COMPLETED | Ecallantide (Repeat Dose Only) | 0 | |
| Double Blind Treatment Period | NOT COMPLETED | Ecallantide / Ecallantide | 1 | |
| Double Blind Treatment Period | NOT COMPLETED | Placebo / Ecallantide | 0 | |
| Double Blind Treatment Period | NOT COMPLETED | Ecallantide (Repeat Dose Only) | 0 | |
| Repeat Dose Treatment Period | STARTED | Ecallantide / Ecallantide | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events81
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 | Diarrhoea | Gastrointestinal disorders | Double Blind - Ecallantide | 3 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | Double-Blind Placebo | 0 | 36 | |
| other | Diarrhoea | Gastrointestinal disorders | Repeat-Dosing Ecallantide | 3 | 67 | |
| other | Headache | Nervous system disorders | Double Blind - Ecallantide | 4 | 36 | |
| other | Headache | Nervous system disorders | Double-Blind Placebo | 2 | 36 | |
| other | Headache | Nervous system disorders | Repeat-Dosing Ecallantide | 10 | 67 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Double Blind - Ecallantide | 0 | 36 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Double-Blind Placebo | 2 | 36 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Repeat-Dosing Ecallantide | 4 | 67 | |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Double Blind - Ecallantide | 2 | 36 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double Blind - Ecallantide | ||
| Total, all-cause mortality | Double-Blind Placebo | ||
| Total, all-cause mortality | Repeat-Dosing Ecallantide | ||
| Total, other adverse events | Double Blind - Ecallantide | 13 | 36 |
| Total, other adverse events | Double-Blind Placebo | 7 | 36 |
| Total, other adverse events | Repeat-Dosing Ecallantide | 22 | 67 |
| Total, serious adverse events | Double Blind - Ecallantide | 3 | 36 |
| Total, serious adverse events | Double-Blind Placebo | 2 | 36 |
| Total, serious adverse events | Repeat-Dosing Ecallantide | 7 | 67 |
Source ClinicalTrials.gov
Papers6
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/NCT00262080
GET https://conductscience.org/api/trials/v1/NCT00262080/results?page=2