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NCT03891901 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
A Phase 2 study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03891901: Completed Phase 2 study of Tuberculosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03891901 is a Phase 2 study of Tuberculosis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 24 participants, below the 934-participant average among 29 other Tuberculosis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03891901, a Phase 2 study of Tuberculosis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin. The results of this trial will determine the imatinib dose to be studied in a subsequent Phase IIB treatment trial of imatinib as an adjunctive therapy with an antimicrobial regimen (rifabutin, pyrazinamide (PZA), isoniazid (INH) and ethambutol) for drug-sensitive TB.
Primary Outcome
Immunologic effects of the study treatment are assessed by counting myelomonocytic cells in blood samples. An increase in myelomonocytic cells is used to determine the appropriate therapeutic dose of imatinib.
Conditions Studied
Interventions
- DRUG Imatinib
- DRUG Rifabutin
- DRUG Isoniazid
Study Locations (1)
Georgia
- Emory University DAIDS TB Non-Network CRS - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-10-27 |
| Est. Completion | 2022-08-30 |
| Phase | Phase 2 |
What the finished NCT03891901 record still lists
NCT03891901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 934-participant average among 29 other Tuberculosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Tuberculosis appearing as the primary indexed condition, and to 3 interventions - of which Imatinib is the first listed.
NCT03891901 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03891901 about?
NCT03891901 is a clinical study titled "A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin". The purpose of this study is to evaluate the safety, pharmacokinetics, and effects of imatinib on myelopoiesis in adults when given with and without isoniazid and rifabutin. The results of this trial will determine the imatinib dose to be studied in a subsequent Phase IIB treatment trial of imatinib...
What is the current status of trial NCT03891901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2020-10-27. Estimated completion is 2022-08-30.
What conditions does trial NCT03891901 study?
This clinical trial studies the following conditions: Tuberculosis.
What interventions are being tested in trial NCT03891901?
The interventions under investigation include: Imatinib (DRUG), Rifabutin (DRUG), Isoniazid (DRUG).
Who is sponsoring clinical trial NCT03891901?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03891901 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tuberculosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03891901's enrollment target sits among peer trials
24 29th of 29 higher than 1 of 29 other Tuberculosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tuberculosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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