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NCT02404155 · ClinicalTrials.gov registry record · NA
Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)
A NA study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- NA
- Development phase
- 274
- Enrollment target
NCT02404155 is a NA study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 274 participants.
The verdict
NCT02404155, a NA study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- NA
- Development phase
- 274 participants
- Enrollment target
Study Summary
Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant SZ, especially for African-Americans (AA). Recent evidence suggests that low Absolute Neutrophil Counts (ANC), either at baseline or during treatment are a significant barrier to CLZ use in AA patients in the US, where guidelines mandate CLZ discontinuation if ANC drops below 1500 cells/mm3. The investigators group has found that discontinuation of CLZ in AA patients is over twice that in European-American (EA) patients (N\~400; 42% vs.19%, P=0.041) and initiation rates are 50% lower. In a Statewide study (N=1875), the investigators reported that discontinuation was more frequently due to neutropenia in the AA sample, though no AA had developed agranulocytosis (8 cases in EA). Benign Ethnic Neutropenia (BEN) in people of African ancestry, including AAs, identifies a group (50% of AA) with low ANCs but no increased risk of agranulocytosis or infection. Low baseline or in-treatment fluctuations requiring CLZ discontinuation under current prescribing guidelines are common in CLZ-treated persons with BEN. In the investigators recent pilot study of N=12 AA patients with BEN, treatment was safely and successfully continued with CLZ despite low baseline ANC (outside current guidelines). Recent evidence implicates a polymorphism in the Duffy Antigen Receptor Chemokine (DARC) gene in the pathophysiology of BEN. In homozygotes (FY-/-) for the DARC null allele, mean within-subject neutrophil counts are reduced, resulting in sporadic ANC \<1500 cells/mm3 in 10-15% of people with the allele. In population studies, the FY-/- genotype is found in 0.01% of EAs, 99.3% of sub-Saharan Africans (SSA), and 68% of AAs. Further, a missense DARC mutation has been reported to interact with the DARC FY-/- in determining
Interventions
- DRUG Clozapine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2015-07 |
| Est. Completion | 2021-10-26 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02404155
The ClinicalTrials.gov registry entry for NCT02404155 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 274 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Clozapine is the first listed.
NCT02404155 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02404155 about?
NCT02404155 is a clinical study titled "Biomarker and Safety Study of Clozapine in Patients With Benign Ethnic Neutropenia (BEN)". Clozapine (CLZ) is the most effective antipsychotic for treatment-refractory schizophrenia (SZ). Despite the overwhelming evidence of superior efficacy, CLZ is infrequently prescribed in the US, at a considerably lower rate than the estimated prevalence of treatment-resistant SZ, especially for Afri...
What is the current status of trial NCT02404155?
This trial is currently completed. It is a NA study. The enrollment target is 274 participants. The study started on 2015-07. Estimated completion is 2021-10-26.
What interventions are being tested in trial NCT02404155?
The interventions under investigation include: Clozapine (DRUG).
Who is sponsoring clinical trial NCT02404155?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
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