Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446310
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-31
Brief Title:
Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Sponsor:
Qilu Pharmaceutical Hainan Co Ltd
Organization:
Qilu Pharmaceutical Hainan Co Ltd
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled Multicentre Phase 3 Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This a multicentre study that consists of a 12-week double-blind period and a 14-week open-label extension period and a 1-week follow-up period
Detailed Description:
Total study duration for a single subject is 31 to 32 weeks with a 4-week screening period a 12-week double-blind period a 14-week open-label extension period and a 1-week follow-up period
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session The total dose of the investigational product will be determined based on the subjects prescription dry body weight
The primary objective of the study is
To evaluate the efficacy and safety of QLG2198 05 μgkg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus
QLG2198 will be administered in the double-blind and open-label period 3 times a week at the end of each dialysis session The total dose of the investigational product will be determined based on the subjects prescription dry body weight
The primary objective of the study is
To evaluate the efficacy and safety of QLG2198 05 μgkg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus
Study Oversight
Has Oversight DMC:
None
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?:
None