Ignite Creation Date:
2024-05-06 @ 3:07 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04521114
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2019-11-18
Brief Title:
Leronlimab PRO 140 in Patients With Nonalcoholic Steatohepatitis
Sponsor:
CytoDyn Inc
Organization:
CytoDyn Inc
Study Overview
Official Title:
A Phase II Multi-center Two-Part Three-Arm Dose-Ranging Study of the Safety and Efficacy of Leronlimab PRO 140 in Adult Patients With Nonalcoholic Steatohepatitis NASH
Status:
COMPLETED
Status Verified Date:
2023-01
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:
NASH
Brief Summary:
This is a phase II study of of Leronlimab PRO 140-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis NASH
Detailed Description:
This is an exploratory phase II multi-center two-part study Part 1 randomized placebo-controlled two-arm with 60 patients Part 2 non-randomized single-arm open-label with 30 patients designed to evaluate the safety and efficacy of leronlimab after subcutaneous SC administration in patients with NASH for 13 weeks
A Follow Up visit was conducted 28 3 days after receiving the last study treatment ie after last dose of Leronlimab PRO 140 or placebo
A Follow Up visit was conducted 28 3 days after receiving the last study treatment ie after last dose of Leronlimab PRO 140 or placebo
Study Oversight
Has Oversight DMC:
None
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?:
None