Trial · NCT01420627
EZN-2279 in Patients With ADA-SCID
NCT01420627, Phase 3, Completed, Leadiant Biosciences, Inc.; results first posted 2020-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EZN-2279 in Patients With ADA-SCID. Trials, record NCT01420627. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01420627
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EZN-2279 in Patients With ADA-SCID
- NCT number
- NCT01420627
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Leadiant Biosciences, Inc.
- Conditions
- ADA-SCID, Adenosine Deaminase Deficiency, Severe Combined Immunodeficiency
- Interventions
- EZN-2279, Adagen
- First posted
- 2011-08-19
- Last updated
- 2020-04-16
- Results first posted
- 2020-04-16
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | Baseline through Week T-21 | Number of patients with total erythrocyte dAXP concentration from a trough blood sample \<0.02 mmol/L |
| Secondary | Safety Summary Data | Through end of EZN-2279 study treatment, up to 203 weeks | Summary of adverse events and serious adverse events |
| Secondary | Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period | From Baseline through Week T-21 | Trough ADA activity, mmol/h/L |
| Secondary | Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period | Through end of EZN-2279 study treatment, up to 203 weeks | Trough ADA activity levels, mmol/h/L |
| Secondary | Summary of Trough dAXP Levels in EZN-2279 Treatment Period | From Baseline through Week T-21 | Trough dAXP levels, mmol/L |
| Secondary | Summary of Trough dAXP Levels in EZN-2279 Maintenance Period | Through end of EZN-2279 study treatment, up to 203 weeks | Trough dAXP levels, mmol/L |
| Secondary | Number of Patients With Infections and Hospitalizations | Through end of EZN-2279 study treatment, up to 203 weeks | Infections were documented clinically with signs and symptoms without microbiologic cultures or with positive viral or bacterial cultures |
| Secondary | Duration of Hospitalization | Through end of EZN-2279 study treatment, up to 203 weeks | |
| Secondary | Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period | From Week 34 to End of Study/Early Discontinuation, up to 203 weeks | Number of patients with total erythrocyte dAXP concentration from a trough blood sample \<0.02 mmol/L |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | Baseline through Week T-21 | Completer | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Summary Data | Through end of EZN-2279 study treatment, up to 203 weeks | As-treated | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Summary of Trough ADA Activity Levels in EZN-2279 Treatment Period | From Baseline through Week T-21 | Completer | mmol/h/L | MEDIAN |
| SECONDARY | Summary of Trough ADA Activity Levels in EZN-2279 Maintenance Period | Through end of EZN-2279 study treatment, up to 203 weeks | Completer | mmol/h/L | MEDIAN |
| SECONDARY | Summary of Trough dAXP Levels in EZN-2279 Treatment Period | From Baseline through Week T-21 | Completer | mmol/L | MEDIAN |
| SECONDARY | Summary of Trough dAXP Levels in EZN-2279 Maintenance Period | Through end of EZN-2279 study treatment, up to 203 weeks | Completer | mmol/L | MEDIAN |
| SECONDARY | Number of Patients With Infections and Hospitalizations | Through end of EZN-2279 study treatment, up to 203 weeks | As-treated | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Hospitalization | Through end of EZN-2279 study treatment, up to 203 weeks | As-treated population who were hospitalized | Days | MEAN |
| SECONDARY | Number of Patients Detoxified At Each Visit in EZN-2279 Maintenance Period | From Week 34 to End of Study/Early Discontinuation, up to 203 weeks | Completer | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group171
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Baseline | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-1 | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-3 | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-5 | 5 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-7 | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-8 | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-9 | 3 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-10 | 5 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-11 | 6 | Participants | |
| Number of Patients Detoxified At Each Visit in EZN-2279 Treatment Period | EZN-2279 | Week T-13 | 6 | Participants |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Adagen Lead-in Period | STARTED | Adagen/EZN-2279 | 7 | |
| Adagen Lead-in Period | COMPLETED | Adagen/EZN-2279 | 7 | |
| Adagen Lead-in Period | NOT COMPLETED | Adagen/EZN-2279 | 0 | |
| EZN-2279 Treatment Period | STARTED | Adagen/EZN-2279 | 7 | |
| EZN-2279 Treatment Period | COMPLETED | Adagen/EZN-2279 | 6 | |
| EZN-2279 Treatment Period | NOT COMPLETED | Adagen/EZN-2279 | 1 | |
| EZN-2279 Maintenance Period | STARTED | Adagen/EZN-2279 | 6 | |
| EZN-2279 Maintenance Period | COMPLETED | Adagen/EZN-2279 | 6 | |
| EZN-2279 Maintenance Period | NOT COMPLETED | Adagen/EZN-2279 | 0 |
Source ClinicalTrials.gov
Adverse events194
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 | Non-cardiac chest pain | General disorders | Adagen | 0 | 7 | |
| other | Non-cardiac chest pain | General disorders | EZN-2279 | 2 | 7 | |
| other | Pyrexia | General disorders | Adagen | 0 | 7 | |
| other | Pyrexia | General disorders | EZN-2279 | 2 | 7 | |
| other | Asthenia | General disorders | Adagen | 0 | 7 | |
| other | Asthenia | General disorders | EZN-2279 | 1 | 7 | |
| other | Chills | General disorders | Adagen | 0 | 7 | |
| other | Chills | General disorders | EZN-2279 | 1 | 7 | |
| other | Fatigue | General disorders | Adagen | 0 | 7 | |
| other | Fatigue | General disorders | EZN-2279 | 1 | 7 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adagen | 0 | 7 |
| Total, all-cause mortality | EZN-2279 | 0 | 7 |
| Total, other adverse events | Adagen | 6 | 7 |
| Total, other adverse events | EZN-2279 | 7 | 7 |
| Total, serious adverse events | Adagen | 0 | 7 |
| Total, serious adverse events | EZN-2279 | 4 | 7 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adagen vs EZN-2279: deaths from any cause | Trial comparisons |
| Adagen vs EZN-2279: 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/NCT01420627
GET https://conductscience.org/api/trials/v1/NCT01420627/results?page=2