Trial · NCT02093923
A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
NCT02093923, Phase 1, Completed, Shire; results first posted 2016-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants. Trials, record NCT02093923. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02093923
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
- NCT number
- NCT02093923
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 38 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- DX-2930, Placebo
- First posted
- 2014-03-21
- Last updated
- 2021-05-27
- Results first posted
- 2016-08-01
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | From Day 1 up to final follow-up (Day 123) | A SAE was any adverse experience occurring at any dose that resulted in any of the following outcomes: Death, Life-threatening experience, required inpatient hospitalization or prolongation of existing hospitalization. Resulted in persistent or significant disability or incapacity. Was a congenital anomaly or birth defect. Was considered to be an important medical event. An AE was considered treatment-emergent if the onset time was after administration of study drug through the Day 120 post-dose final follow-up visit or, in the event that onset time preceded study drug administration, the AE increased in severity during the 120-day post-dose follow-up period. |
| Secondary | Maximum Plasma Concentration (Cmax) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinetic (PK) parameter Cmax data were reported. |
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | PK parameter Tmax data were reported. |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | PK paramenter AUC data were reported. |
| Secondary | Apparent Clearance (CL/F) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | PK parameter CL/F data were reported. |
| Secondary | Apparent Volume of Distribution (Vd/F) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | PK parameter Vd/F data were reported. |
| Secondary | Terminal Elimination Half-Life (t1/2) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | PK parameter t(1/2) data were reported. |
| Other | HAE Attack Rate Per Week From Day 8 to Day 50 | Day 8 to Day 50 | Analysis of this outcome measure was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the pre-specified assessment period (Days 8 to 50; predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week was a covariate, treatment group is a fixed effect, and participant was a random effect in the GEE model with independence working correlation structure. |
| Other | HAE Attacks Per Week From Day 8 to Day 92 | Day 8 to Day 92 | This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 92 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure. |
| Other | HAE Attacks Per Week From Day 8 to Day 64 | Day 8 to Day 64 | This endpoint analysis was based on participants in the 300 mg, 400 mg, and placebo dose groups with a historical baseline attack rate of at least 2 attacks over the last 3 months prior to enrollment. The result is based on General Estimating Equation (GEE) analysis of repeated counts per week during the prespecified assessment period (Day 8 to Day 64 predicted to correspond to a period of notable drug exposure). Baseline HAE attack rate per week is a covariate, treatment group is a fixed effect, and participant is a random effect in the GEE model with independence working correlation structure. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | From Day 1 up to final follow-up (Day 123) | Safety Population included all randomized participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Plasma Concentration (Cmax) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Days | MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | day*nanogram per milliliter (day*ng/mL) | MEAN |
| SECONDARY | Apparent Clearance (CL/F) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Liter per day (L/day) | MEAN |
| SECONDARY | Apparent Volume of Distribution (Vd/F) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Liter (L) | MEAN |
| SECONDARY | Terminal Elimination Half-Life (t1/2) | Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120 | Pharmacokinectic (PK) population included all randomized HAE participants in the safety population who had sufficient blood samples to obtain a plasma concentration versus time profile. | Day | MEAN |
| OTHER_PRE_SPECIFIED | HAE Attack Rate Per Week From Day 8 to Day 50 | Day 8 to Day 50 | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | HAE attacks per week | MEAN |
| OTHER_PRE_SPECIFIED | HAE Attacks Per Week From Day 8 to Day 92 | Day 8 to Day 92 | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | HAE Attacks per Week | MEAN |
| OTHER_PRE_SPECIFIED | HAE Attacks Per Week From Day 8 to Day 64 | Day 8 to Day 64 | All randomized participants in the 300 mg, 400 mg, and placebo groups who received at least 1 dose of study drug and who had a historical baseline attack rate of at least 2 attacks in the 3 months prior to enrollment. | HAE Attacks per Week | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group82
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 Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 1 | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 2 | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 3 | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 4 | Serious Adverse Events | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | Placebo | Serious Adverse Events | 1 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 1 | Treatment Emergent Adverse Events | 1 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 2 | Treatment Emergent Adverse Events | 3 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 3 | Treatment Emergent Adverse Events | 2 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | DX-2930, Cohort 4 | Treatment Emergent Adverse Events | 8 | Participants | |
| Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) | Placebo | Treatment Emergent Adverse Events | 10 | Participants |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DX-2930, Cohort 1 | 4 | |
| Overall Study | STARTED | DX-2930, Cohort 2 | 4 | |
| Overall Study | STARTED | DX-2930, Cohort 3 | 5 | |
| Overall Study | STARTED | DX-2930, Cohort 4 | 12 | |
| Overall Study | STARTED | Placebo | 13 | |
| Overall Study | Total Treated | DX-2930, Cohort 1 | 4 | |
| Overall Study | Total Treated | DX-2930, Cohort 2 | 4 | |
| Overall Study | Total Treated | DX-2930, Cohort 3 | 5 | |
| Overall Study | Total Treated | DX-2930, Cohort 4 | 11 | |
| Overall Study | Total Treated | Placebo | 13 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events85
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 | DX-2930, Cohort 1 | 0 | 4 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | DX-2930, Cohort 2 | 3 | 4 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | DX-2930, Cohort 3 | 1 | 5 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | DX-2930, Cohort 4 | 5 | 11 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Placebo | 9 | 13 | |
| other | Abdominal Pain | Gastrointestinal disorders | DX-2930, Cohort 1 | 0 | 4 | |
| other | Abdominal Pain | Gastrointestinal disorders | DX-2930, Cohort 2 | 0 | 4 | |
| other | Abdominal Pain | Gastrointestinal disorders | DX-2930, Cohort 3 | 0 | 5 | |
| other | Abdominal Pain | Gastrointestinal disorders | DX-2930, Cohort 4 | 1 | 11 | |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo | 1 | 13 |
1 to 10 of 85Source ClinicalTrials.gov
See all 85 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DX-2930, Cohort 1 | 0 | 4 |
| Total, all-cause mortality | DX-2930, Cohort 2 | 0 | 4 |
| Total, all-cause mortality | DX-2930, Cohort 3 | 0 | 5 |
| Total, all-cause mortality | DX-2930, Cohort 4 | 0 | 11 |
| Total, all-cause mortality | Placebo | 0 | 13 |
| Total, other adverse events | DX-2930, Cohort 1 | 1 | 4 |
| Total, other adverse events | DX-2930, Cohort 2 | 3 | 4 |
| Total, other adverse events | DX-2930, Cohort 3 | 2 | 5 |
| Total, other adverse events | DX-2930, Cohort 4 | 8 | 11 |
| Total, other adverse events | Placebo | 10 | 13 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28225674 | DERIVED |
Source 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 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.
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