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Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.
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.
Official title: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3, Clinical Study of QLG2198 in Haemodialysis Adult Subjects With Moderate-to-Severe Pruritus
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
194
Start Date
2024-06-18
Completion Date
2025-08-03
Last Updated
2024-06-21
Healthy Volunteers
No
Conditions
Interventions
QLG2198
Participants receive QLG2198 three times a week (0,5 micrograms/kg dry body weight). QLG21988 is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis.
Placebo
Participants receive Placebo three times a week (0,5 micrograms/kg dry body weight). Placebo is administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each dialysis
Locations (3)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Jieyang People's Hospital
Jieyang, Guangdong, China
Shandong Provincial Hospital
Jinan, Shandong, China