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Studie GSK3965193 u zdravých účastníků a samostatně a v kombinaci s Bepirovirsenem u účastníků žijících s chronickou infekcí hepatitidou B

19. května 2026 aktualizováno: GlaxoSmithKline

Čtyřdílná, randomizovaná, dvojitě zaslepená (části 1, 2A, 3 a 4), multicentrická, placebem kontrolovaná studie k posouzení bezpečnosti, snášenlivosti, farmakokinetiky a farmakodynamiky monoterapie GSK3965193 u zdravých účastníků au účastníků žijících s chronická infekce hepatitidy B; a GSK3965193 v kombinaci s Bepirovirsenem u účastníků žijících s chronickou infekcí hepatitidou B

Tato vícedílná studie fáze 1/2a je první studií u člověka (FTIH) navržená k vyhodnocení bezpečnosti, snášenlivosti a farmakokinetiky (PK) jednorázové (část 1) a opakovaných dávek (část 2) GSK3965193 v zdraví účastníci. Část 3 bude hodnotit schopnost GSK3965193 snižovat povrchový antigen viru hepatitidy B (HBsAg) u účastníků žijících s chronickou infekcí hepatitidy B (PLWCHB). Část 4 bude hodnotit bezpečnost a snášenlivost kombinované terapie s GSK3965193 a bepirovirsenem a potenciál ovlivnit trvalou virologickou odpověď u PLWCHB.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

74

Fáze

  • Fáze 2
  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Francie
      • Grenoble, Francie, 38043
        • GSK Investigational Site
      • Nantes, Francie, 44000
        • GSK Investigational Site
      • Rennes, Francie, 35033
        • GSK Investigational Site
  • Itálie
      • Milan, Itálie, 20122
        • GSK Investigational Site
      • Monza MB, Itálie, 20900
        • GSK Investigational Site
  • Jižní Korea
      • Daegu, Jižní Korea, 41944
        • GSK Investigational Site
      • Pusan, Jižní Korea, 49241
        • GSK Investigational Site
      • Seoul, Jižní Korea, 05505
        • GSK Investigational Site
  • Kanada
    • Alberta
      • Calgary, Alberta, Kanada, T2N 4Z6
        • GSK Investigational Site
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • GSK Investigational Site
  • Spojené království
      • Cambridge, Spojené království, CB2 2GG
        • GSK Investigational Site
      • London, Spojené království, SW17 0QT
        • GSK Investigational Site
      • London, Spojené království, W2 1NY
        • GSK Investigational Site
  • Thajsko
      • Bangkok, Thajsko, 10330
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Popis

Kritéria pro zařazení:

  • Část 1 a 2: Účastníci ve věku od 18 do 55 let včetně, v době podpisu informovaného souhlasu.
  • Část 3 a 4: Účastníci ve věku od 18 do 65 let včetně, v době podpisu informovaného souhlasu.
  • Tělesná hmotnost >=50 kilogramů (kg) a index tělesné hmotnosti v rozmezí 18-32 kilogramů na metr čtvereční (kg/m^2) (včetně).
  • Muž nebo žena: a. Části 1 a 2: Pouze žena s nefertilním potenciálem. b. Část 3 a 4: žena v nefertilním věku nebo žena ve fertilním věku, která není těhotná ani nekojí a používá antikoncepční metodu, která je vysoce účinná.
  • Schopný dát podepsaný informovaný souhlas.
  • Dodatečná kritéria zahrnutí pro PLWCHB (části 3 a 4).
  • Účastníci, kteří prokázali chronickou infekci virem hepatitidy B (HBV) >=6 měsíců před screeningem.
  • Účastníci, kteří v současné době dostávají stabilní terapii NA (např. tenofovir disoproxil, tenofovir alafenamid, entekavir).
  • Koncentrace HBsAg v plazmě nebo séru >100 IU/ml.
  • Plazmatická nebo sérová koncentrace deoxyribonukleové kyseliny (DNA) HBV
  • E-antigen viru hepatitidy B (HBeAg) pozitivní nebo negativní.
  • Alaninaminotransferáza (ALT)

Kritéria vyloučení:

  • Kritéria vyloučení pro zdravé účastníky:
  • Pozitivní protilátka proti viru hepatitidy A (HAV Ab imunoglobulin M [IgM]) nebo pozitivní na HBV, virus hepatitidy C (HCV) nebo virus lidské imunodeficience (HIV) při screeningu.
  • ALT >1krát ULN.
  • Bilirubin >1,5násobek ULN (izolovaný bilirubin >1,5násobek ULN je přijatelný, pokud je bilirubin frakcionován a přímý bilirubin
  • Opravený interval QT (QTc) > 450 milisekund (ms).
  • Známky a příznaky připomínající onemocnění Coronavirus 2019 (COVID-19).
  • Účastníci se známými pozitivními kontakty na COVID-19 za posledních 14 dní.
  • Pro účastníky části 2A: i. Periferní neuropatie v osobní nebo rodinné anamnéze. ii. Skóre >=4 na klinickém skórovacím systému v Torontu pro polyneuropatii.
  • Současné nebo předchozí užívání výrobků obsahujících tabák nebo nikotin (například cigarety, nikotinové náplasti nebo elektronická zařízení) během 6 měsíců před screeningem a/nebo mít kuřáckou krabičku > 5 let v balení.
  • Kritéria vyloučení pro PLWCHB:
  • Klinicky významné abnormality v anamnéze, kromě chronické infekce HBV.
  • Souběžná infekce s HCV, HIV nebo virem hepatitidy D (HDV) nebo v anamnéze.
  • Anamnéza nebo podezření na cirhózu jater a/nebo známky cirhózy.
  • Diagnostikovaný nebo suspektní hepatocelulární karcinom.
  • Anamnéza malignity za posledních 5 let s výjimkou specifických rakovin, které jsou vyléčeny chirurgickou resekcí (např. rakovina kůže).
  • Anamnéza vaskulitidy nebo přítomnost příznaků a známek potenciální vaskulitidy [např. vaskulitická vyrážka, kožní ulcerace, opakovaná přítomnost krve v moči bez identifikované příčiny] nebo anamnéza/přítomnost jiných onemocnění, která mohou být spojena s vaskulitidou (např. systémový lupus erythematodes revmatoidní artritida, recidivující polychondritida, mononeuritida multiplex).
  • Anamnéza extrahepatálních poruch pravděpodobně souvisejících s imunitními stavy HBV (např. nefrotický syndrom, jakýkoli typ glomerulonefritidy, polyarteritis nodosa, kryoglobulinémie, nekontrolovaná hypertenze).
  • Anamnéza zneužívání/závislosti na alkoholu nebo drogách: a. Současné užívání alkoholu podle posouzení výzkumníka může potenciálně narušovat compliance účastníků. b. Anamnéza nebo současné zneužívání/závislost na drogách, jak bylo zkoušejícím posouzeno jako potenciálně narušující komplianci účastníků.
  • Anamnéza nebo jiný důkaz krvácení z jícnových varixů.
  • Zdokumentovaná anamnéza nebo jiný důkaz metabolického onemocnění jater do 1 roku od randomizace.
  • Periferní neuropatie v osobní nebo rodinné anamnéze.
  • Skóre > 4 na klinickém skórovacím systému v Torontu pro polyneuropatii.
  • Anamnéza užívání nebo současného užívání jakékoli systémové antineoplastické (včetně ozařování) nebo imunomodulační léčby (včetně systémových perorálních kortikosteroidů, interferonu nebo pegylovaného interferonu) během 8 týdnů před první dávkou studovaného léku nebo očekávání, že taková léčba bude potřeba kdykoliv během studia.
  • Abnormální a klinicky významný nález na 12svodovém EKG.
  • V současné době užíváte nebo užíváte do 3 měsíců od screeningu jakékoli imunosupresivní léky (např. prednison), kromě krátkodobé terapie (
  • Účastníci vyžadující antikoagulační terapie.
  • Předchozí léčba jakýmkoli oligonukleotidem nebo malou interferující RNA (siRNA) během 12 měsíců před prvním dnem podávání.
  • Pozitivní test na infekci COVID-19.
  • Účastníci se známými pozitivními kontakty na COVID-19 za posledních 14 dní.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Part 1: Cohort 1 - Placebo/GSK3965193 Dose 2/Dose 3/Dose 4
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 2.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 1 - GSK3965193 Dose 1/Placebo/Dose 3/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 3 and Dose 3 was higher than Dose 1.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Placebo/Dose 4
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 4 oral solution on Day 1 in Treatment Period 4. Dose 4 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 1 - GSK3965193 Dose 1/Dose 2/Dose 3/Placebo
Healthy participants received a single dose of GSK3965193 Dose 1 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 2 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 3 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 3 of GSK3965193 was higher than Dose 2 and Dose 2 was higher than Dose 1.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 2 - Placebo/GSK3965193 Dose 6/Dose 7/Dose 8
Healthy participants received a single dose of placebo oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 6.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 2 - GSK3965193 Dose 5/Placebo/Dose 7/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 7 and Dose 7 was higher than Dose 5.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Placebo/Dose 8
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of placebo oral solution on Day 1 in Treatment Period 3; further followed by a single dose of GSK3965193 Dose 8 oral solution on Day 1 in Treatment Period 4. Dose 8 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 1: Cohort 2 - GSK3965193 Dose 5/Dose 6/Dose 7/Placebo
Healthy participants received a single dose of GSK3965193 Dose 5 oral solution on Day 1 in Treatment Period 1; followed by a single dose of GSK3965193 Dose 6 oral solution on Day 1 in Treatment Period 2; followed by a single dose of GSK3965193 Dose 7 oral solution on Day 1 in Treatment Period 3; further followed by a single dose of placebo oral solution on Day 1 in Treatment Period 4. Dose 7 of GSK3965193 was higher than Dose 6 and Dose 6 was higher than Dose 5.
Lék: GSK3965193
GSK3965193 was administered
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Komparátor placeba: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Experimentální: Part 2A: Cohort 5 - GSK3965193 Dose 9 BID
Healthy participants received repeat doses of GSK3965193 Dose 9 oral solution BID for 14 days. Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
Lék: GSK3965193
GSK3965193 was administered
Experimentální: Part 2A: Cohort 3 - GSK3965193 Dose 5 BID
Healthy participants received repeat doses of GSK3965193 Dose 5 oral solution BID for 14 days. Dose 5 of GSK3965193 was higher than Dose 9 but lower than Dose 10.
Lék: GSK3965193
GSK3965193 was administered
Experimentální: Part 2A: Cohort 4 - GSK3965193 Dose 6 BID
Healthy participants received repeat doses of GSK3965193 Dose 6 oral solution BID for 14 days. Dose 6 of GSK3965193 was higher than Dose 10 but lower than Dose 7.
Lék: GSK3965193
GSK3965193 was administered
Experimentální: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fasted/Fed
Healthy participants received GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
Lék: GSK3965193
GSK3965193 was administered
Experimentální: Part 2B: Cohort 6 - GSK3965193 Dose 10 Fed/Fasted
Healthy participants received GSK3965193 Dose 10 oral tablets under fed condition in Treatment Period 1, followed by GSK3965193 Dose 10 oral tablets under fasted condition in Treatment Period 2. Dose 10 of GSK3965193 was higher than Dose 5 but lower than Dose 6.
Lék: GSK3965193
GSK3965193 was administered
Komparátor placeba: Part 3: Cohort 7 - Placebo
Participants living with chronic hepatitis B infection (PLWCHB) on stable nucleos(t)ide analog (NA) therapy received repeat doses of placebo oral tablets for 28 days. Participants who completed placebo monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen subcutaneous (SC) injection from Day 43.
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Lék: Bepirovirsen
Bepirovirsen was administered
Experimentální: Part 3: Cohort 7 - GSK3965193 Dose 9
PLWCHB on stable NA therapy received repeat doses of GSK3965193 Dose 9 oral tablets for 28 days. Participants who completed GSK3965193 monotherapy were given the option to receive subsequent treatment of optional open label bepirovirsen SC injection from Day 43. Dose 9 of GSK3965193 was higher than Dose 4 but lower than Dose 5.
Lék: GSK3965193
GSK3965193 was administered
Lék: Bepirovirsen
Bepirovirsen was administered
Experimentální: Part 4: Cohort 8 - Placebo + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive placebo oral tablets plus bepirovirsen SC injection for 28 days. All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
Lék: Placebo to match GSK3965193
Placebo to match GSK3965193 was administered
Lék: Bepirovirsen
Bepirovirsen was administered
Experimentální: Part 4: Cohort 8 - GSK3965193 + Bepirovirsen
PLWCHB on stable NA therapy were planned to receive GSK3965193 oral tablets plus bepirovirsen SC injection for 28 days. All participants were further planned to continue receiving bepirovirsen SC injection after 28 days.
Lék: GSK3965193
GSK3965193 was administered
Lék: Bepirovirsen
Bepirovirsen was administered

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Časové okno: From the start of study intervention (Day 1) up to 12 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator. An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration. Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
From the start of study intervention (Day 1) up to 12 weeks
Part 2A: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Časové okno: From the start of study intervention (Day 1) up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator. An AE was considered treatment emergent if the AE onset date was on or after study intervention start date.
From the start of study intervention (Day 1) up to 6 weeks
Part 2B: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Časové okno: From the start of study intervention (Day 1) up to 9 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator. An AE was considered treatment emergent if the AE onset date was on or after study intervention start date (i.e., Day 1) till Day 5 after study intervention administration. Any AE which started post Day 5 of study intervention administration was not considered as TEAE.
From the start of study intervention (Day 1) up to 9 weeks
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Časové okno: From the start of study intervention (Day 1) up to 6 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator. An AE was considered treatment emergent if the AE onset or worsen date was on or after study intervention start date. Data for the placebo or GSK3965193 monotherapy phase were presented.
From the start of study intervention (Day 1) up to 6 weeks
Part 4: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Časové okno: From the start of study intervention (Day 1) up to 48 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator. An AE would be considered treatment emergent if the AE onset or worsen date was on or after study intervention start date.
From the start of study intervention (Day 1) up to 48 weeks
Part 1: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Časové okno: At Day 2
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, red blood cell (RBC) count, hemoglobin, hematocrit, RBC indices (mean corpuscular volume [MCV] and mean corpuscular hemoglobin [MCH]), white blood cell (WBC) count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), blood urea nitrogen (BUN), creatinine, glucose (non-fasting), potassium, sodium, calcium, aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT), alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin. Clinical significance of laboratory parameters was determined by the investigator.
At Day 2
Part 2A: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Časové okno: Up to 21 days
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin. Urine samples were analyzed using automated urinalysis or urine dipstick. Microscopic examination was performed if abnormal blood or protein was present in the urine sample. Clinical significance of laboratory parameters was determined by the investigator.
Up to 21 days
Part 2B: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Časové okno: Up to 9 weeks
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin. Urine samples were analyzed using automated urinalysis or urine dipstick. Microscopic examination was performed if abnormal blood or protein was present in the urine sample. Clinical significance of laboratory parameters was determined by the investigator.
Up to 9 weeks
Part 3: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Časové okno: Up to 35 days
Blood samples were collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin. Clinical significance of laboratory parameters was determined by the investigator. Data for the placebo or GSK3965193 monotherapy phase were presented.
Up to 35 days
Part 3: Number of Participants With Clinically Significant Urinalysis Parameters
Časové okno: Up to 28 days
Urine samples were analyzed using automated urinalysis or urine dipstick. Microscopic examination was performed if abnormal blood or protein was present in the urine sample. Clinical significance of laboratory parameters was determined by the investigator. Data for the placebo or GSK3965193 monotherapy phase were presented.
Up to 28 days
Part 4: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Časové okno: Up to 48 weeks
Blood samples were planned to be collected to analyze hematology and clinical chemistry parameters: platelet count, RBC count, hemoglobin, hematocrit, RBC indices (MCV and MCH), WBC count with differential (neutrophils, lymphocytes, monocytes, eosinophils, and basophils), BUN, creatinine, glucose (non-fasting), potassium, sodium, calcium, AST/SGOT, ALT/SGPT, alkaline phosphatase, total bilirubin, indirect bilirubin, direct bilirubin, total protein, and albumin. Urine samples were planned to be analyzed using automated urinalysis or urine dipstick. Microscopic examination was planned to be performed if abnormal blood or protein was present in the urine sample. Clinical significance of laboratory parameters would be determined by the investigator.
Up to 48 weeks
Part 1: Number of Participants With Clinically Significant Vital Sign Findings
Časové okno: Up to 12 weeks
Vital signs included systolic blood pressure (SBP) and diastolic blood pressure (DBP), pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of the vital sign findings was determined by the investigator.
Up to 12 weeks
Part 2A: Number of Participants With Clinically Significant Vital Sign Findings
Časové okno: Up to 21 days
Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of the vital sign findings was determined by the investigator.
Up to 21 days
Part 2B: Number of Participants With Clinically Significant Vital Sign Findings
Časové okno: Up to 9 weeks
Vital signs included SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of the vital sign findings was determined by the investigator.
Up to 9 weeks
Part 3: Number of Participants With Clinically Significant Vital Sign Findings
Časové okno: Up to 35 days
Vital signs included temperature, SBP and DBP, pulse and respiratory rate and were measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of the vital sign findings was determined by the investigator. Data for the placebo or GSK3965193 monotherapy phase were presented.
Up to 35 days
Part 4: Number of Participants With Clinically Significant Vital Signs Findings
Časové okno: Up to 48 weeks
Vital signs were planned to include temperature, SBP and DBP, pulse and respiratory rate and were planned to be measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of the vital sign findings would be determined by the investigator.
Up to 48 weeks
Part 1: Number of Participants With Clinically Significant Electrocardiogram [ECG] Findings
Časové okno: Up to 12 weeks
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine. The parameters collected were PR, QRS, QT, and corrected QT (QTc) intervals. Clinical significance of ECG parameters was determined by the investigator.
Up to 12 weeks
Part 2A: Number of Participants With Clinically Significant ECG Findings
Časové okno: Up to 21 days
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine. The parameters collected were PR, QRS, QT, and QTc intervals. Clinical significance of ECG parameters was determined by the investigator.
Up to 21 days
Part 3: Number of Participants With Clinically Significant ECG Findings
Časové okno: Up to 35 days
A 12-lead ECG was recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine. The parameters collected were PR, QRS, QT, and QTc intervals. Clinical significance of ECG parameters was determined by the investigator. Data for the placebo or GSK3965193 monotherapy phase were presented.
Up to 35 days
Part 4: Number of Participants With Clinically Significant ECG Findings
Časové okno: Up to 25 weeks
A 12-lead ECG was planned to be recorded with the participant in a semi-supine position after 5 minutes of rest using an ECG machine. The parameters planned to be collected were PR, QRS, QT, and QTc intervals. Clinical significance of ECG findings would be determined by the investigator.
Up to 25 weeks
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 7
Časové okno: Baseline and Day 7
Sensory nerve conduction testing was performed to detect neuropathy in participants. Nerve conduction velocity (NCV) and nerve conduction amplitude were determined. Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing. Mean (arithmetic mean) of two measurements were considered as Baseline. Number of participants with 25 percent (%) decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 7 was reported.
Baseline and Day 7
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 14
Časové okno: Baseline and Day 14
Sensory nerve conduction testing was performed to detect neuropathy in participants. NCV and nerve conduction amplitude were determined. Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing. Mean (arithmetic mean) of two measurements were considered as Baseline. Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 14 was reported.
Baseline and Day 14
Part 2A: Number of Participants With Changes in Sensory Nerve Conduction at Day 42
Časové okno: Baseline and Day 42
Sensory nerve conduction testing was performed to detect neuropathy in participants. NCV and nerve conduction amplitude were determined. Sensory nerve conduction studies at Baseline were collected twice, one at the time of screen and one prior to dosing. Mean (arithmetic mean) of two measurements were considered as Baseline. Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 42 was reported.
Baseline and Day 42
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 15
Časové okno: Baseline and Day 15
Sensory nerve conduction testing was performed to detect neuropathy in participants. NCV and nerve conduction amplitude were determined. The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement. Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 15 for the placebo or GSK3965193 monotherapy phase was reported.
Baseline and Day 15
Part 3: Number of Participants With Changes in Sensory Nerve Conduction at Day 29
Časové okno: Baseline and Day 29
Sensory nerve conduction testing was performed to detect neuropathy in participants. NCV and nerve conduction amplitude were determined. The best measurement out of Screening and Day -1 was considered as Baseline, best being the higher measurement. Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from Baseline at Day 29 for the placebo or GSK3965193 monotherapy phase was reported.
Baseline and Day 29
Part 4: Number of Participants With Changes in Sensory Nerve Conduction
Časové okno: Baseline up to 29 days
Sensory nerve conduction testing was planned to be performed to detect neuropathy in participants. NCV and nerve conduction amplitude were planned to be determined. Number of participants with 25% decrease in NCV and 50% decrease in nerve conduction amplitude from baseline was planned to be reported.
Baseline up to 29 days
Part 1: Area Under the Concentration-time Curve (AUC) From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC[0-inf]) of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours (h) post-dose
Part 2A: AUC Over the Dosing Interval Tau (AUC[0-tau]) of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods. As the dosing interval Tau was 12 hours, AUC(0-tau) is the same as AUC from time zero to 12 hours after dosing (AUC[0-12]).
Pre-dose and 15 minutes (min), 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, and 12 h post-first dose on Day 14
Part 1: Maximum Observed Concentration (Cmax) of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: Cmax of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 1: Time to Maximum Observed Plasma Drug Concentration (Tmax) of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: Tmax of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 1: Apparent Terminal Half-life (T1/2) of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, and 96 hours post-dose
Part 2A: T1/2 of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4, h, 8 h, and 12 h post-first dose on Day 1; pre-morning dose on Days 2 through 6 and Days 12 through 13; pre-dose and 15 min, 30 min, 1 h, 2h, 4 h, 8 h, 12 h, 24 h, 48 h, and 72 h post-first dose on Day 14
Part 3: Maximum Reduction of Serum HBsAg Levels From Baseline
Časové okno: From Baseline (Pre-dose on Day 1) up to 6 weeks
Blood samples were collected from participants to assess HBsAg levels for the placebo or GSK3965193 monotherapy phase. Baseline was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Posterior mean and associated 95 percent (%) credible interval were derived for maximum reduction of serum HBsAg levels from Baseline using Bayesian mixed model repeated measures. The data presented are mean referring to posterior mean, with 95% confidence interval referring to 95% credible interval.
From Baseline (Pre-dose on Day 1) up to 6 weeks
Part 4: Number of Participants Achieving Complete Response
Časové okno: Up to 48 weeks
Blood samples were planned to be collected to assess HBsAg and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Complete response is defined HBsAg and HBV DNA below lower limit of quantification (LLOQ) for 6 consecutive months after the planned end of treatment.
Up to 48 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
Part 2B: Cmax of GSK3965193 Following Single Dose Administration
Časové okno: Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 15 min, 30 min, 1 h, 2 h, 3 h, 4 h, 6 h, 8 h, 12 h, 16 h, 24 h, 48 h, and 72 h post-dose
Part 3: AUC(0-tau) of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Part 3: Cmax of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Part 3: Tmax of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Part 3: T1/2 of GSK3965193 Following Repeat Dose Administration
Časové okno: Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Blood samples were collected at indicated time points for PK analysis of GSK3965193. PK analysis was conducted using standard non-compartmental methods.
Pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 1; pre-dose on Day 4, Day 8, Day 11, Day 15, Day 22; pre-dose and 0.25 h, 0.5 h, 1 h, 2, h, 3 h, 4 h, 6 h, 8 h, and 12 h post-dose on Day 28
Part 3: Number of Participants With Greater Than or Equal to [≥] 0.5 Times Log International Units Per Milliliters [IU/mL] Reduction From Baseline in Serum HBsAg Levels
Časové okno: From Baseline (Day 1) up to 42 days
Blood samples were collected from participants at indicated time points to assess HBsAg levels.
From Baseline (Day 1) up to 42 days
Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs Among Participants Opting for Optional Bepirovirsen Treatment
Časové okno: From the start of study intervention up to 54 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any serious adverse event that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; abnormal pregnancy outcomes or other situations as per the medical or scientific judgment of the investigator.
From the start of study intervention up to 54 weeks
Part 3: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters Among Participants Opting for Optional Bepirovirsen Treatment
Časové okno: From Week 7 up to 54 weeks
Blood samples were planned to be collected to analyze clinical chemistry and hematology parameters: hemoglobin, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, platelets, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cells, reticulocytes, ALT, albumin, alkaline phosphatase, AST, bilirubin, calcium corrected for albumin, creatinine, glucose, potassium, and sodium. Urine samples were planned to be analyzed using automated urinalysis or urine dipstick. Microscopic examination was performed if abnormal blood or protein was present in the urine sample. Number of participants with clinically significant clinical chemistry, hematology, and urinalysis parameters were reported. Clinical significance was determined by the investigator.
From Week 7 up to 54 weeks
Part 3: Number of Participants With Clinically Significant Vital Signs Among Participants Opting for Optional Bepirovirsen Treatment
Časové okno: From Week 7 up to 54 weeks
Vital signs were planned to include temperature and were planned to be measured with the participant in semi-supine position after 5 minutes rest. Clinical significance of vital signs was determined by the investigator.
From Week 7 up to 54 weeks
Part 4: Number of Participants With HBsAg Loss
Časové okno: Up to 48 weeks
Blood samples were collected from participants at indicated time points to assess HBsAg levels. HBsAg loss is defined by two consecutive measurements of HBsAg below the LLOQ any time during the study (on-treatment and post-treatment).
Up to 48 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Vyšetřovatelé

  • Ředitel studie: GSK Clinical Trials, GlaxoSmithKline

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

14. dubna 2022

Primární dokončení (Aktuální)

19. května 2025

Dokončení studie (Aktuální)

8. dubna 2026

Termíny zápisu do studia

První předloženo

8. dubna 2022

První předloženo, které splnilo kritéria kontroly kvality

8. dubna 2022

První zveřejněno (Aktuální)

15. dubna 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 214760
  • 2021-005117-13 (Číslo EudraCT)
  • 2023-509684-24 (Jiný identifikátor: EU CTR)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

IPD pro tuto studii bude zpřístupněna prostřednictvím stránky žádosti o data klinické studie.

Časový rámec sdílení IPD

IPD bude k dispozici do 6 měsíců od zveřejnění výsledků primárních cílů, klíčových sekundárních cílů a údajů o bezpečnosti studie.

Kritéria přístupu pro sdílení IPD

Přístup je poskytován po předložení návrhu výzkumu a obdržení souhlasu nezávislého kontrolního panelu a poté, co je uzavřena dohoda o sdílení dat. Přístup je poskytován na počáteční období 12 měsíců, ale v odůvodněných případech lze povolit prodloužení až o dalších 12 měsíců.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Žloutenka typu B

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Lebanon

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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