Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-01 @ 4:58 AM
Study NCT ID:
NCT07170800
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets
Sponsor:
WestVac Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Randomized, Active-controlled Clinical Study to Compare the Efficacy and Safety of Different Combination Regimens of JDB0131 Benzenesulfonate Tablets With Delamanid in Patients With Rifampin-resistant Tuberculosis (JD-RISE)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
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:
None
Brief Summary:
This is a multicenter, randomized, open-label, active-controlled clinical study designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of different doses of JDB0131 benzenesulfonate tablets compared with delamanid in combination with bedaquiline, linezolid, levofloxacin (moxifloxacin)/clofazimine, etc. in the treatment of patients with drug-resistant (including rifampicin-resistant) tuberculosis for 8 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: