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RECRUITING
NCT06446310
PHASE3

Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus

Sponsor: Qilu Pharmaceutical (Hainan) Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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