Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-02-20 @ 3:44 PM
Study NCT ID:
NCT02968927
Status:
UNKNOWN
Last Update Posted:
2019-01-10
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TB Host Directed Therapy
Sponsor:
The Aurum Institute NPC
Organization:
Study Overview
Official Title:
A Ph2 Randomized Trial to Evaluate the Safety Preliminary Efficacy and Biomarker Response of Host Directed Therapies Added to Rifabutin-modified Standard Therapy in Adults With Drug-Sensitive Smear-Positive Pulmonary TB
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TBHDT
Brief Summary:
To examine the safety and preliminary efficacy of multiple adjunctive host directed TB therapies (TB HDT), to assess their potential to shorten TB treatment and/or prevent permanent lung damage.
Detailed Description:
OBJECTIVES:
To determine the safety and preliminary efficacy of 4 TB HDT candidates:
1. Safety (treatment emergent serious adverse events and SUSARs)
2. Microbiologic effects in sputum (culture conversion, change in MGIT TTP) and blood (WBA)
3. PET/CT imaging
4. Serum markers of inflammation
5. Effects on Mtb-specific and general immune function
6. Pulmonary effects (spirometry, 6MWT, O2 saturation, and St. George Respiratory Symptom Questionnaire) In each case, TB HDT effects will be determined by comparison to patients treated with standard TB therapy alone with regard to a common set of primary and secondary endpoints.
PRIMARY ENDPOINTS
1. For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs).
2. For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs).
To determine the safety and preliminary efficacy of 4 TB HDT candidates:
1. Safety (treatment emergent serious adverse events and SUSARs)
2. Microbiologic effects in sputum (culture conversion, change in MGIT TTP) and blood (WBA)
3. PET/CT imaging
4. Serum markers of inflammation
5. Effects on Mtb-specific and general immune function
6. Pulmonary effects (spirometry, 6MWT, O2 saturation, and St. George Respiratory Symptom Questionnaire) In each case, TB HDT effects will be determined by comparison to patients treated with standard TB therapy alone with regard to a common set of primary and secondary endpoints.
PRIMARY ENDPOINTS
1. For auranofin, everolimus, and vitamin D: the proportions of patients experiencing suspected unexpected serious adverse reactions (SUSARs).
2. For CC-11050: the proportion of patients experiencing treatment emergent serious adverse events (SAEs).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: