Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2026-02-20 @ 12:31 PM
Study NCT ID:
NCT01887366
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2013-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Organization:
Study Overview
Official Title:
A 12-week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Once-Weekly Intra-Muscular Injections of TV-1380 (150 mg/Week or 300 mg/Week) as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects
Status:
COMPLETED
Status Verified Date:
2015-10
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 primary objective of this study is to assess the efficacy and safety of TV-1380 \[Recombinant human serum albumin (HSA) mutated butyrylcholinesterase (AlbuBChE)\] in facilitating abstinence in cocaine-dependent subjects.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: