NCT04999787已完成2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2021年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period
研究概览
简要总结
This study is a multi-center, randomized, double-blind, placebo-controlled study. About 90 liver disease subjects with moderate or above pruritus are planned to be enrolled. They will be randomized to two dose groups (0.3 μg/kg and 0.6 μg/kg) and a placebo control group at a 1:1:1 ratio, with about 30 subjects in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 and ≤ 75 years old, male or female;
- •Body mass index (BMI): ≥ 18 kg/m2 and ≤ 35 kg/m2;
- •Suffering from liver diseases with itching, including but not limited to viral hepatitis, autoimmune liver disease, drug-induced liver disease, alcoholic liver disease, and other liver diseases;
- •The mean baseline WI-NRS score before randomization suggests moderate to severe itching (≥ 4 points) and the last two WI-NRS scores ≥ 4 points.
- •Subjects who are willing to sign an informed consent form in written form fully understand the objectives and purposes of the study, and are willing to comply with the study protocol before any of the study-related procedures to start.
排除标准
- •Decompensated hepatic cirrhosis in the following cases:
- •History of liver transplant, expecting a liver transplant surgery, or the current model for end-stage liver disease (MELD) score ≥ 18;
- •Grade 3 ascites;
- •History of gastrointestinal hemorrhage (excluding haemorrhoidal haemorrhage) within one month before randomization;
- •Hepatic encephalopathy;
- •Having dermatitis atopic, chronic urticaria, psoriasis or other skin diseases that the investigator determines will disturb the assessment of itching or having itching caused by other diseases.
- •History of allergy to opioids, such as urticaria;
- •Cannot ensure the stable use of drugs for the treatment of baseline liver diseases from 4 weeks before the lead-in phase to the end of the follow-up period, such as ursodeoxycholic acid (UCDA), antiviral drugs (excluding interferon), fibrates, etc.;
- •Cannot ensure the stable use of drugs that may affect the efficacy or safety evaluations from the first 14 days of the lead-in phase to the end of the follow-up period, such as antipsychotics, sedative hypnotics, anxiolytics, antidepressants (excluding selective serotonin reuptake inhibitors), immunosuppressants/immunomodulators (such as systemic glucocorticoid therapy [excluding topical application], ciclosporin A, azathioprine, methotrexate, etc.);
- •Using drugs with unclear half-life that may affect the efficacy evaluation within 14 days before the lead-in period, or drugs that affect the efficacy evaluation before randomization, and the last time of use is shorter than 5 half-lives from the lead-in phase (refer to the specific drug labeling), including but not limited to bile acid binding resin (colestyramine, etc.), pregnane X receptor (PXR) agonist (rifampicin, etc.), selective serotonin reuptake inhibitor (SSRIs) (sertraline, etc.), antihistamines, gabapentin, pregabalin, interferon, obeticholic acid or other opioids;
- •Using the following topical drugs within 3 days before the lead-in phase: antihistamines and glucocorticoids;
- •Having received traditional Chinese medicine treatment, physical phototherapy or artificial liver treatment that may affect the efficacy evaluation within 14 days before randomization;
- •Complicated with other serious underlying diseases that the investigator judges may increase the risk of the trial, affect the compliance of the subjects with the protocol or affect the subjects with completion of the trial, including but not limited to malignant tumors (excluding tumors that had been cured [no evidence of disease recurrence within 5 years]), serious cardiovascular and cerebrovascular diseases, mental and neurological disorders, etc.;
- •Complicated with uncontrolled severe infections (including severe abdominal infection, upper respiratory tract infection, lower respiratory tract infection, urinary system infection, etc.);
- •Itching secondary to obstruction of bile duct (excluding primary sclerosing cholangitis (PSC));
- •With the following abnormal laboratory tests results:
- •eGFR < 30 mL/min/1.73 m2;
- •Serum bilirubin total (TBIL) > 15 × ULN;
- •INR > 1.5 × ULN;
- •Potassium ion concentration < 3.0 mmol/L;
- •History of medication or drug abuse and/or alcohol abuse within 3 months prior to screening (alcohol abuse is defined as an average of > 2 units of alcohol consumed per day [1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor with 40% alcohol, or 150 mL of wine] within 3 months);
- •Having participated in other clinical trials within 3 months prior to screening (defined as having received investigational drug or placebo);
- •Positive for human immunodeficiency virus (HIV) antibody or syphilis antibody at screening;
- •Pregnant and breastfeeding females; women of child-bearing potential or men who are unwilling to use contraception during the trial; or subjects who are planning pregnancy within 3 months after the completion of the trial (including male subjects);
- •Expected survival < 3 months;
- •Subjects judged by the investigator to have any other factors unsuitable for involvement in the study.
研究组 & 干预措施
HSK21542
Experimental
HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg
干预措施: HSK21542 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period
时间窗: Day 1 to Day 28
In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching
Changes in daily WI-NRS scores from baseline during the follow-up period
时间窗: Day 29 to Day 31
Area under curve (AUC) of daily WI-NRS scores during the administration period
时间窗: Day 1 to Day28
Changes in quality of life (evaluated by Skindex-16 scale) from baseline during the administration period
时间窗: Day 1 to Day 28
The proportion of subjects whose daily WI-NRS scores improve by ≥ 3 points and ≥ 4 points compared with baseline during the administration period
时间窗: Day 1 to Day28
Changes in WI-NRS per unit time (per day) from baseline during the administration period
时间窗: Day 1 to Day 28
次要结局
未报告次要终点
研究者
研究点 (1)
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