Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-03-05 @ 3:47 AM
Study NCT ID:
NCT03396393
Status:
UNKNOWN
Last Update Posted:
2018-01-23
First Post:
2018-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of DHA in Systemic Lupus Erythematosus Patients
Sponsor:
Kunming Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Phase II, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Efficacy of Dihydroartemisinin Tablets in Patients With Systemic Lupus Erythematosus
Status:
UNKNOWN
Status Verified Date:
2018-01
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:
The primary objective of the study is to assess the efficacy of DHA in patients with SLE.
Detailed Description:
This is a Phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the Safety, Pharmacokinetics and Efficacy of four oral treatment regimens of DHA versus placebo while taking standard of care (SOC) treatment with corticosteroids in adult subjects with Systemic Lupus Erythematosus (SLE).
Study Oversight
Has Oversight DMC:
False
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?: