- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04317209
A Study of SHR0410 in Hemodialysis Patients With Pruritus
21. maj 2020 opdateret af: Jiangsu HengRui Medicine Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study on Safety, Tolerability and Pharmacokinetics of SHR0410 in Hemodialysis Subjects With Moderate to Severe Pruritus
The aim of this study is to evaluate the safety, tolerability and pharmacokinetics of SHR0410 in hemodialysis patients with moderate to severe pruritus
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
54
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Guangzhou, Kina
- Rekruttering
- The First Affiliated Hospital of Sun Yat-Sen University
-
Kontakt:
- Wei Chen
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Males or females aged 18-65 (inclusive);
- Weight (> 50 kg);
- Patients with end-stage renal disease receiving hemodialysis (including hemodialysis and hemofiltration) three times a week for at least 3 months.
- VAS≥4 at screening
Exclusion Criteria:
- New York cardiac function classification (NYHA) ≥ level III in the current or previous 6 months;
- Pruritus caused by other than end-stage renal disease or its complications..
- History of malignancy
- Any physical or mental illness or condition, as determined by the study investigator, that may increase the risk of participating the trial, affect the subject's compliance with the protocol, or affect the subject's completion of the trial
- Positive urine drug screening; Or a history of drug abuse;
- Urine test positive for nicotine;
- Alcohol breath test positive;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or transglutaminase (GGT) was 1.5 times higher than the upper limit of normal value (ULN), or total bilirubin was 1.5 times higher than the upper limit of normal value (ULN);
- Screening for hepatitis c antibody (HCVAb), syphilis antibody or human immunodeficiency virus (HIV) antibody positive; Or hepatitis B is active;
- Abnormal electrocardiogram considered inappropriate to participate in this study by the investigator
- positive for human chorionic gonadotropin (hCG) blood test
- A history of allergies to opioids
- Has used opioids within one week prior to the current visit, or cannot avoid to use opioids other than the study drug during the study period;
- Change the treatment regimen for pruritus within 14 days, or cannot avoid to change the treatment regimen for pruritus during the study period
- Received Ultraviolet phototherapy within 14 days before screening visit; Or cannot avoid to receive ultraviolet light therapy during the study.
- Change the treatment regimen of gabapentin, pregabalin, or duloxetine within 14 days before screening visit; Or the treatment regimen of gabapentin, pregabalin, or duloxetine cannot be avoided to be changed during the study period.
- Change the treatment regimen of medications within 14 days that may affect the judgment of antipruritic effect; Or the treatment regimen cannot be avoided to be changed during the study
- Using topical antipruritic drugs, such as creams and patches with moisturizing or antipruritic effects at present.
- Kidney transplantation is expected during the study period;
- Subjects who had Participated in this trial (defined by signing the informed consent);
- Subjects who had Participated in clinical trials of any other drugs within the previous 3 months; Or plan to participate in other drug trials during the trial period;
- Subjects who had Participated in the clinical trial of any medical device within the previous 3 months; Or participate in other medical device tests during the trial period.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: Placebo
|
administered intravenously
|
Eksperimentel: SHR0410 low dosage
|
administered intravenously
Andre navne:
|
Eksperimentel: SHR0410 medium dosage
|
administered intravenously
Andre navne:
|
Eksperimentel: SHR0410 high dosage
|
administered intravenously
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The incidence and severity of any adverse events that occurred between the first administration and the 48-hour period following the last administration
Tidsramme: up to 7 days
|
To evaluate the safety and tolerability of repeated doses of SHR0410
|
up to 7 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Area under drug-time curve
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
peak time
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
peak concentration
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
half-life
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
apparent clearance rate
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
apparent distribution volume
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
The ratio of AUC0-t after the first and last administration.
Tidsramme: up to 7 days
|
To evaluate pharmacokinetic (PK) of repeated doses of SHR0410
|
up to 7 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. maj 2020
Primær færdiggørelse (Forventet)
1. december 2020
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
16. marts 2020
Først indsendt, der opfyldte QC-kriterier
20. marts 2020
Først opslået (Faktiske)
23. marts 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SHR0410-103
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Kløe
-
RDD Pharma LtdTrukket tilbage
-
Ain Shams UniversityAfsluttetUræmisk pruritus hos hæmodialysepatienterEgypten
-
Sanwa Kagaku Kenkyusho Co., Ltd.AfsluttetUræmisk pruritus hos hæmodialysepatienterJapan
-
Alexandria UniversityAfsluttetHæmodialyse-associeret pruritusEgypten
-
First Affiliated Hospital of Zhejiang UniversityShenyang Sunshine Pharmaceutical Co., LTD.UkendtForbedring af pruritus hos hæmodialysepatienterKina
-
Swiss-American Products, IncMcGill University; Hospital de readaptation Villa Medica; Precision ConsultingAfsluttetKløe | Kløe | Brænd pruritusCanada
-
Meir Medical CenterTrukket tilbageUfrivillig vandladning | Vulvar pruritus | Vulvar kontaktdermatitisIsrael
-
Yangzhou UniversityAfsluttet
-
Bell International LaboratoriesAfsluttet
-
Toray Industries, IncAfsluttetPruritus med kronisk leversygdomJapan
Kliniske forsøg med SHR0410
-
Atridia Pty Ltd.Linear Clinical ResearchAfsluttet
-
Jiangsu HengRui Medicine Co., Ltd.Rekruttering
-
Atridia Pty Ltd.Afsluttet
-
Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnu
-
Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnuPostoperativ smerte ved laparoskopisk kirurgi
-
Jiangsu HengRui Medicine Co., Ltd.Afsluttet