Trial · NCT03149315
Inhibition of Anaphylaxis by Ibrutinib
NCT03149315, Phase 2, Completed, Ann & Robert H Lurie Children's Hospital of Chicago; results first posted 2025-01-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Inhibition of Anaphylaxis by Ibrutinib. Trials, record NCT03149315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03149315
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Inhibition of Anaphylaxis by Ibrutinib
- NCT number
- NCT03149315
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Conditions
- Food Allergy, Anaphylaxis Food
- Interventions
- Ibrutinib
- First posted
- 2017-05-11
- Last updated
- 2025-01-17
- Results first posted
- 2025-01-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods | 7 days | The primary outcome was the number of ibrutinib doses (2, 4, or 7 doses) required to maximally suppress food skin prick reactivity to foods. All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Skin testing to peant and tree nuts was done at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib). |
| Secondary | Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity | 7 days | The primary outcome was to determine the fewest ibrutinib doses (2, 4, or 7 doses) required to suppress basophil reactivity (BAT). All participants received 420 mg ibrutinib orally once daily for 2, 4, or 7 doses after undergoing baseline screening criteria. Basophil activation testing was perfmored at baseline and repeated at each visit on days 2, 4, and 7 (corresponding to 2, 4, or 7 doses of ibrutinib). |
| Secondary | Time to Recovery of Skin Test Reactivity | 30 days | Another secondary outcome was to determine the timing of when skin prick testing (SPT) response to peanut or tree nuts returned to baseline compared to basophil activation test (BAT) responses. Participants underwent SPT and BAT weekly after cessation of ibrutinib therapy. SPT and BAT that were ≥80% of baseline values were considered to have "returned to baseline." |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods | 7 days | doses | MEAN | |
| SECONDARY | Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity | 7 days | doses | MEAN | |
| SECONDARY | Time to Recovery of Skin Test Reactivity | 30 days | weeks | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Doses of Ibrutinib for Maximal Suppression of Skin Prick Test Size to Foods | Ibrutinib | 2 | Standard Deviation 0 | doses | |
| Number of Doses of Ibrutinib for Maximal Suppression of Basophil Reactivity | Ibrutinib | 2 | Standard Deviation 0 | doses | |
| Time to Recovery of Skin Test Reactivity | Ibrutininb | 1.24 | Standard Deviation 0.6633 | weeks |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibrutinib | 6 | |
| Overall Study | COMPLETED | Ibrutinib | 6 | |
| Overall Study | NOT COMPLETED | Ibrutinib | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Shortness of breath | Respiratory, thoracic and mediastinal disorders | All Participants | 1 | 6 | 6 |
| other | Nausea | Gastrointestinal disorders | All Participants | 1 | 6 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | 0 | 6 |
| Total, other adverse events | All Participants | 1 | 6 |
| Total, serious adverse events | All Participants | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29360526 | 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.
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/NCT03149315
GET https://conductscience.org/api/trials/v1/NCT03149315/registered