Trial · NCT02404155
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)
NCT02404155, Not applicable, Completed, University of Maryland, Baltimore; results first posted 2023-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN). Trials, record NCT02404155. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02404155
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)
- NCT number
- NCT02404155
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 274 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- Schizophrenia
- Interventions
- Clozapine
- First posted
- 2015-03-31
- Last updated
- 2023-01-31
- Results first posted
- 2023-01-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | 24 week period baseline and endpoint | |
| Primary | Number of Episodes of Agranulocytosis (Count). | 6 months |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | 24 week period baseline and endpoint | Genetic information was only able to be collected and analyzed on 249 of t he 274 overall participants. | cells/mm3 | MEAN |
| PRIMARY | Number of Episodes of Agranulocytosis (Count). | 6 months | Episodes | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Baseline ANC for CC genotype | 2755.1 | Standard Deviation 1271.5 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Endpoint ANC for CC genotype | 3079.9 | Standard Deviation 1563.0 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Baseline ANC for CT genotype | 4360.6 | Standard Deviation 1779.0 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Endpoint ANC for CT genotype | 4450.3 | Standard Deviation 2398.0 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Baseline WBC for CC genotype | 5478.9 | Standard Deviation 1688.1 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Endpoint WBC for CC genotype | 5766.1 | Standard Deviation 1946.4 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Baseline WBC for CT genotype | 7802.0 | Standard Deviation 2142.0 | cells/mm3 |
| Change in White Blood Cell (WBC) (mm3) and Absolute Neutrophil Counts (ANC) (mm3) in Persons According to Presence of the DARC Null Allele. | Clozapine | Endpoint WBC for CT genotype | 7702.7 | Standard Deviation 2607.5 | cells/mm3 |
| Number of Episodes of Agranulocytosis (Count). | Clozapine | 1 | Episodes |
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 | Clozapine | 274 | |
| Overall Study | COMPLETED | Clozapine | 227 | |
| Overall Study | NOT COMPLETED | Clozapine | 47 |
Source ClinicalTrials.gov
Adverse events49
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 | Abdominal Pain | Gastrointestinal disorders | Clozapine | 91 | 274 | |
| other | Anorexia | General disorders | Clozapine | 51 | 274 | |
| other | Bruising | General disorders | Clozapine | 12 | 274 | |
| other | Constipation | Gastrointestinal disorders | Clozapine | 88 | 274 | |
| other | Diarrhea | Gastrointestinal disorders | Clozapine | 64 | 274 | |
| other | Dizziness | General disorders | Clozapine | 112 | 274 | |
| other | Dry Mouth | General disorders | Clozapine | 65 | 274 | |
| other | Enuresis | Gastrointestinal disorders | Clozapine | 70 | 274 | |
| other | Fever | General disorders | Clozapine | 35 | 274 | |
| other | Headache | General disorders | Clozapine | 86 | 274 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clozapine | 0 | 274 |
| Total, other adverse events | Clozapine | 264 | 274 |
| Total, serious adverse events | Clozapine | 19 | 274 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35358857 | 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/NCT02404155
GET https://conductscience.org/api/trials/v1/NCT02404155/events?page=2