Actively Recruiting
Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Led by Qilu Pharmaceutical (Hainan) Co., Ltd. · Updated on 2024-06-21
194
Participants Needed
3
Research Sites
58 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 3 Study of QLG2198 in Haemodialysis Chinese Adult Subjects With Moderate-to-Severe Pruritus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged between 18 and 85 years
- Have chronic kidney disease and have been on hemodialysis three times a week for at least 12 weeks before screening
- If female, not pregnant or nursing
- Agree to avoid donating sperm or eggs from first dose until 7 days after last dose
- Agree to use contraception during the study and for 7 days after last dose
- Have a prescription dry body weight between 40 and 100 kilograms
You will not qualify if you...
- Planning to receive a kidney transplant during the study
- Have itching only on the palms of the hands
- Have itching only during dialysis sessions
- Have severe liver impairment (Child-Pugh Class C) or liver cirrhosis
- Receiving ongoing ultraviolet treatment
- Have active cancer except fully removed basal or squamous cell skin cancer or carcinoma in situ
- History or suspicion of alcohol or drug abuse/dependence within 12 months before screening
- Started or changed treatment for itching within 2 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Jieyang People's Hospital
Jieyang, Guangdong, China
Actively Recruiting
3
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
Research Team
W
Wu Yidi, M.M
CONTACT
J
Jiang xiaoning, P.M
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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