CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Imatinib +2 moredrug
Likely dose
Isoniazid 300 mgfrom record
Key inclusion· 4
  • Age 18–55 years
  • BMI >18.5 kg/m²
  • At least 8 years formal education with appropriate reading and comprehension skills
  • Able and willing to provide written informed consent
Key exclusion· 9
  • Known infection with Mycobacterium tuberculosis (MTB)
  • HIV positive status
  • Hepatitis B or C infection
  • History of allergy or hypersensitivity to imatinib, isoniazid, or rifabutin

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03891901
NCT03891901Phase 2Completed

IMPACT-TB (Imatinib Mesylate Per Oral as a Clinical Therapeutic for TB): A Phase II Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Mar 27, 2019·Updated Oct 23, 2023

In Brief

A Phase 2 clinical trial evaluating Imatinib, Isoniazid, and 1 other intervention for Tuberculosis. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartOct 27, 2020
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.3 years ago

Interventions

Imatinibdrug

Tablets, administered orally

Isoniaziddrug

300 mg tablets, administered orally

Rifabutindrug

300 mg capsules, administered orally