Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2025-12-17 @ 2:30 AM
Study NCT ID:
NCT06350838
Status:
None
Last Update Posted:
2024-04-05 00:00:00
First Post:
2024-01-28 00:00:00
Brief Title:
Clinical Study to Investigate the Safety and Tolerance of Therapeutic BCG in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Sponsor:
Chengdu CoenBiotech Co Ltd
Organization:
Chengdu CoenBiotech Co., Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Investigate the Safety and Tolerance of Therapeutic Bacillus Calmette-Guerin( BCG) in Postoperative Adjuvant Therapy in Subjects With Moderate to High-risk Non-muscular Invasive Bladder Cancer (NMIBC)
Status:
None
Status Verified Date:
2024-03
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:
The purpose of this study was to evaluate the safety and tolerance, pharmacokinetic characteristics, ablative status, and immune response characteristics of the therapeutic BCG in postoperative adjuvant therapy in subjects with moderate and high-risk non-invasive bladder cancer (NMIBC).
The study consisted of three phases: screening period, administration observation period and safety follow-up period. subjects will be treated with 120 mg BCG.
The study consisted of three phases: screening period, administration observation period and safety follow-up period. subjects will be treated with 120 mg BCG.
Detailed Description:
The purpose of this study was to evaluate the safety and tolerance pharmacokinetic characteristics ablative status and immune response characteristics of the therapeutic BCG in postoperative adjuvant therapy in subjects with moderate and high-risk non-invasive bladder cancer NMIBC
The study consisted of three phases screening period administration observation period and safety follow-up period subjects will be treated with 120 mg BCG
The study consisted of three phases screening period administration observation period and safety follow-up period subjects will be treated with 120 mg BCG
Study Oversight
Has Oversight DMC:
None
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?:
None