Trial · NCT02741596
Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
NCT02741596, Phase 3, Completed, Shire; results first posted 2020-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE. Trials, record NCT02741596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02741596
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Study of DX-2930 (SHP643) to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
- NCT number
- NCT02741596
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 212 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- DX-2930, DX-2930
- First posted
- 2016-04-18
- Last updated
- 2021-06-08
- Other registries' IDs
- eudract:2015-005255-27
- Results first posted
- 2020-05-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of the study up to follow-up (Day 952) | An adverse event (AE) was any untoward medical occurrence in a clinical trial Participant whether or not it appeared to have a causal relationship with the treatment administered. Treatment-emergent AEs were defined as AEs with onset at the time of or following the first exposure to open-label DX-2930 in this study, or medical conditions present prior to the start of treatment but increasing in severity or relationship at the time of or following the start of treatment. |
| Secondary | Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. The treatment period investigator-confirmed HAE attack rate was calculated for each participant as the number of investigator-confirmed HAE attacks occurring during the treatment period (regular dosing stage of the treatment period for rollover participants) divided by the number of days the participant contributed to the treatment period multiplied by 28 days. Rate of investigator-confirmed HAE attacks during the treatment period was reported. |
| Secondary | Rate of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During the Treatment Period | Up to Day 924 | HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Rate of investigator-confirmed HAE attacks requiring acute treatment for each participant as the number of investigator-confirmed HAE attacks occurring during the treatment period (regular dosing stage of the treatment period for rollover participants) divided by the number of days the participant contributed to the treatment period multiplied by 28 days. Rate of investigator-confirmed HAE attacks requiring acute treatment during the treatment period was reported. |
| Secondary | Rate of Moderate or Severe Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Moderate and severe investigator-confirmed HAE attacks were the attacks that were moderate or severe as per the HAE attack assessment and reporting procedures (HAARP) defined severity. The overall severity of attack was determined by the investigator using following definitions: mild (transient or mild discomfort), moderate (mild to moderate limitation in activity), severe (marked limitation in activity). Rate of moderate or severe HAE attacks during the treatment period was reported. |
| Secondary | Rate of High-Morbidity Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. High-morbidity Hereditary Angioedema (HAE) attack was defined as any attack that had at least one of the following characteristics: severe, resulted in hospitalization (except hospitalization for observation lesser than \[\<\] 24 hours), hemodynamically significant (systolic blood pressure \<90 millimeter of mercury \[mmHg\], required intravenous hydration, or associated with syncope or near-syncope) or laryngeal edema. Number of high-morbidity HAE attacks during the treatment period was analyzed and reported using the methods for the overall number of investigator-confirmed HAE attacks with the exception of the monthly line graphs. Rate of high-morbidity HAE attacks during the treatment period was reported. |
| Secondary | Time to First Investigator-Confirmed Hereditary Angioedema (HAE) Attacks in Rollover Participants | Up to Day 924 | HAE attack was defined as a discrete episode during which the participant progressed from no angioedema to symptoms of angioedema. Time to first investigator-confirmed HAE attack was calculated from the time of first open-label dose to the start time of the first investigator-confirmed HAE attack. Time to the first investigator-confirmed HAE attack was analyzed and reported only in rollover safety population. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of the study up to follow-up (Day 952) | Safety population included all participants who received any study drug after entering the DX-2930-04 study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | Safety population included all participants who received any study drug after entering the DX-2930-04 study. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Attacks per month | MEAN |
| SECONDARY | Rate of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During the Treatment Period | Up to Day 924 | Safety population was analyzed, which included all participants who received any study drug after entering the DX-2930-04 study. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Attacks per month | MEAN |
| SECONDARY | Rate of Moderate or Severe Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | Safety population included all participants who received any study drug after entering the DX-2930-04 study. Here, the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Attacks per month | MEAN |
| SECONDARY | Rate of High-Morbidity Hereditary Angioedema (HAE) Attacks During the Treatment Period | Up to Day 924 | Safety population included all participants who received any study drug after entering the DX-2930-04 study. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Attacks per month | MEAN |
| SECONDARY | Time to First Investigator-Confirmed Hereditary Angioedema (HAE) Attacks in Rollover Participants | Up to Day 924 | Rollover Safety Population included subset of participants who participated in the DX-2930-03 (NCT02586805) study and received any study drug after entering the DX-2930-04 study (that is any exposure to open-label DX-2930). Here, data was not planned to be collected and analyzed for Non-rollover participants. | Days | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Rollover Participants | 105 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Non-rollover Participants | 101 | Participants | ||
| Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During the Treatment Period | Rollover Participants | 0.27 | Standard Deviation 0.581 | Attacks per month | |
| Rate of Investigator Confirmed Hereditary Angioedema (HAE) Attacks During the Treatment Period | Non-rollover Participants | 0.22 | Standard Deviation 0.521 | Attacks per month | |
| Rate of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During the Treatment Period | Rollover Participants | 0.20 | Standard Deviation 0.430 | Attacks per month | |
| Rate of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During the Treatment Period | Non-rollover Participants | 0.21 | Standard Deviation 0.517 | Attacks per month | |
| Rate of Moderate or Severe Hereditary Angioedema (HAE) Attacks During the Treatment Period | Rollover Participants | 0.21 | Standard Deviation 0.479 | Attacks per month | |
| Rate of Moderate or Severe Hereditary Angioedema (HAE) Attacks During the Treatment Period | Non-rollover Participants | 0.19 | Standard Deviation 0.512 | Attacks per month | |
| Rate of High-Morbidity Hereditary Angioedema (HAE) Attacks During the Treatment Period | Rollover Participants | 0.03 | Standard Deviation 0.085 | Attacks per month | |
| Rate of High-Morbidity Hereditary Angioedema (HAE) Attacks During the Treatment Period | Non-rollover Participants | 0.04 | Standard Deviation 0.103 | Attacks per month |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rollover Participants | 109 | |
| Overall Study | STARTED | Non-rollover Participants | 103 | |
| Overall Study | COMPLETED | Rollover Participants | 31 | |
| Overall Study | COMPLETED | Non-rollover Participants | 25 | |
| Overall Study | NOT COMPLETED | Rollover Participants | 78 | |
| Overall Study | NOT COMPLETED | Non-rollover Participants | 78 |
Source ClinicalTrials.gov
Adverse events160
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 | Arthralgia | Musculoskeletal and connective tissue disorders | Rollover | 11 | 109 | 20 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Non-Rollover | 16 | 103 | 17 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Rollover | 16 | 109 | 29 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Non-Rollover | 10 | 103 | 12 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Rollover | 8 | 109 | 8 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-Rollover | 9 | 103 | 10 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Rollover | 7 | 109 | 10 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | Non-Rollover | 3 | 103 | 5 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Rollover | 12 | 109 | 13 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Non-Rollover | 9 | 103 | 12 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rollover | 0 | 109 |
| Total, all-cause mortality | Non-Rollover | 0 | 103 |
| Total, other adverse events | Rollover | 100 | 109 |
| Total, other adverse events | Non-Rollover | 96 | 103 |
| Total, serious adverse events | Rollover | 12 | 109 |
| Total, serious adverse events | Non-Rollover | 9 | 103 |
Source ClinicalTrials.gov
Papers5
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rollover Participants vs Non-rollover Participants: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
| Rollover vs Non-Rollover: deaths from any cause | Trial comparisons |
| Rollover vs Non-Rollover: 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.
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/NCT02741596
GET https://conductscience.org/api/trials/v1/NCT02741596/events?page=2