PruritusPhase 2NCT04999787
A Clinical Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of HSK21542 Injection in Liver Disease Subjects With Pruritus
A Phase 2 study testing HSK21542 in people with Pruritus, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pruritus
- What is being tested?
- HSK21542
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2021to 3 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Pruritus
- Being tested
- HSK21542, Placebo
- Medical subject headings
- Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK21542Drug
HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| HSK21542 | Experimental | HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg Receives: Drug: HSK21542 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period
In the NRS score, 0-10 represents different degrees of itching, the larger the number, the more severe the itching
Measured: 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
Measured: Day 1 to Day28
Area under curve (AUC) of daily WI-NRS scores during the administration period
Measured: Day 1 to Day28
Changes in WI-NRS per unit time (per day) from baseline during the administration period
Measured: Day 1 to Day 28
Changes in quality of life (evaluated by Skindex-16 scale) from baseline during the administration period
Measured: Day 1 to Day 28
Changes in daily WI-NRS scores from baseline during the follow-up period
Measured: Day 29 to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start16 Sep 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PruritusStudies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999787
- Sponsor's protocol ID
- HSK21542-204
- Status last verified
- Oct 2022
- First submitted
- 4 Aug 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04999787
- Acronym / sponsor ID
- HSK21542-204
- Conditions
- Pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HSK21542 | Experimental | Drug: HSK21542HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- Decompensated hepatic cirrhosis in the following cases:
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK21542HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg | Drug | HSK21542 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period
Time frame: 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
The proportion of subjects whose daily WI-NRS scores improve by ≥ 3 points and ≥ 4 points compared with baseline during the administration period
Time frame: Day 1 to Day28
Area under curve (AUC) of daily WI-NRS scores during the administration period
Time frame: Day 1 to Day28
Changes in WI-NRS per unit time (per day) from baseline during the administration period
Time frame: Day 1 to Day 28
Changes in quality of life (evaluated by Skindex-16 scale) from baseline during the administration period
Time frame: Day 1 to Day 28
Changes in daily WI-NRS scores from baseline during the follow-up period
Time frame: Day 29 to Day 31
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HSK21542 in people with Pruritus, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in daily Worst Itching Intensity Numerical Rating Scale (WI-NRS) scores from baseline during the administration period (time frame: Day 1 to Day 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.