Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-24 @ 11:02 PM
Study NCT ID:
NCT04255069
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2020-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
Sponsor:
TaiwanJ Pharmaceuticals Co., Ltd
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of JKB-122 in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis
Status:
UNKNOWN
Status Verified Date:
2020-02
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:
A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis
Detailed Description:
This is a Phase 2 study in which JKB-122 is given once daily for 52 weeks to subjects with Nonalcoholic steatohepatitis (NASH) with Fibrosis who have biopsy reading more than NAS 4 with a fibrosis reading more than 1 and no cirrhosis. Subjects will be at least 18 years of age, either male or female.
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?: