A Phase 3 interventional study of QLG2198 and Placebo in Uremic Pruritus, sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd.. Recruiting at 3 sites in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Qilu Pharmaceutical (Hainan) Co., Ltd. (part of Qilu Pharmaceutical Co., Ltd.) · Phase 3, Interventional, and Treatment
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.
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 subject's prescription dry body weight.
The primary objective of the study is:
To evaluate the efficacy and safety of QLG2198 0.5 μg/kg compared to placebo in reducing the intensity of itch in HD subjects with moderate-to-severe pruritus.
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 194 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Qilu Pharmaceutical (Hainan) Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Interventions: Drug: QLG2198 Injection
Drug: QLG2198
Interventions: Drug: Placebo Injection
Drug: Placebo
Interventions: Drug: QLG2198 Injection
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.
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
Change from baseline in the weekly mean of the Worst Itch Numeric Rating Scale (WI-NRS) score
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.patients will be asked to indicate the intensity of the worst itching they experienced over the past 24 hours by marking one of 11 numbers, from 0 to 10, that best describes it, where "0" is labeled with the anchor phrase "no itching" and "10" is labeled "worst itching imaginable."
Time frame: Week 4 of double-blind period
Proportion of subjects achieving ≥3-point improvement from baseline with respect to the weekly mean of the WI-NRS
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Time frame: Week 4 、Week 8、 Week 12 of double-blind period
Proportion of subjects achieving ≥4-point improvement from baseline with respect to the weekly mean of the WI-NRS
The degree of the most intense itching within a day will be assessed using Worst Itch Numeric Rating Scale (WI-NRS) scores.
Time frame: Week 4 、Week 8、 Week 12 of double-blind period
Change from baseline in itch-related Quality of Life (QoL) assessed by the 5-D itch scale total score
The 5-D itch scale is a questionnaire where patients assess the 5 dimensions of itch (degree, duration, direction, disability, and distribution).The total score is the sum of the numeric value of each answered question.
Time frame: Week 4 、Week 8、Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Change from baseline in itch-related QoL assessed by the Skindex-10 scale total score
The Skindex-10 scale is a questionnaire that measures QoL in relationship to the itch intensity.Patients are asked to mark 1 of 7 boxes numbered from 0(labeled with the anchor phrase "never bothered") to 6 (labeled as "always bothered") for each of the 10 questions describing how often they have been bothered by their itch and its impact over the past week. The total score is the sum of the numeric value of each answered question. The total score is subdivided into 3 domain scores, which are sums of the scores of the following questions: disease domain (questions 1 to 3),mood/emotional distress domain (questions 4 to 6), and social functioning domain (questions 7 to 10).
Time frame: Week 4 、Week 8、 Week 12 of double-blind period,Week 4 、Week 8、Week 12 、Week 15 of open-label extension period
Patient Global Impression of Change
The Patient Global Impression of Change is a questionnaire that assesses the change in itch compared to the itch at the start of the study.The scale has only 1 item, and the patient is asked to mark the category that best describes the change in itch ranging from "Very Much Improved" to"Very Much Worse"
Time frame: End of double-blind period, week 12
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Feb 2025, 8 months after the start.
Of 42 industry-sponsored phase 3 interventional studies under Pruritus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 27. This study's planned 8 months is below that.
Counting every sponsor, half of 48 studies reached it within 19 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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