Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-31 @ 2:56 AM
Study NCT ID:
NCT04335357
Status:
UNKNOWN
Last Update Posted:
2020-04-06
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Sponsor:
Tiburio Therapeutics
Organization:
Study Overview
Official Title:
A One Year, Randomized, Double-Blind, Placebo-Controlled Study of TBR-760 in Adult Patients With Non-Functioning Pituitary Adenomas
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_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:
None
Brief Summary:
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks.
Detailed Description:
This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, efficacy, PK, and PD of the chimeric dopamine-somatostatin receptor agonist, TBR-760, in adult patients with NFPA over 52 weeks. Approximately 150 patients will be enrolled.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: