drugset / Trial / NCT03941496

Azacytidine During Anti-tuberculosis Therapy

Phase 1/2 Withdrawn Andrew Dinardo Bristol-Myers Squibb · collab

NaSequentialOpen-labelTreatment

Summary

Tuberculosis has been shown to make immune genes inaccessible and slows immune response The purpose of this research is to see if if azacitidine is safe and can return the ability of the body to resist tuberculosis (TB), a contagious infection that attacks the lungs. Individuals with tuberculosis are being asked to participate. Some will receive a drug to restore a host immunity while others can choose to receive standard of care. All patients will continue to receive standard of care tuberculosis therapy regardless of whether they chose to participate in the study. This study is a Phase Ib/IIa single-institution, open-label, non-randomized clinical trial of sub-cutaneous azacitidine in pulmonary TB patients during the continuation phase of ATT.

Timeline

Start: 2022-10
Primary completion: 2023-05
Completion: 2023-05

Outcome

Outcome not reported

Stopped: “The study was halted prematurely due to Bristol-Myers Squibb's (BMS) decision to withdraw support for this study.”

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitidine	Other / unclassified	5 mg/m2	Subcutaneous
Subject	Azacitidine	Other / unclassified	15 mg/m2	Subcutaneous
Subject	Azacitidine	Other / unclassified	30 mg/m2	Subcutaneous
Subject	Azacitidine	Other / unclassified	50 mg/m2	Subcutaneous
Subject	Azacitidine	Other / unclassified	75 mg/m2	Subcutaneous