Badanie GSK3965193 u zdrowych uczestników i samodzielnie oraz w połączeniu z bepirowirenem u uczestników żyjących z przewlekłym zakażeniem wirusem zapalenia wątroby typu B
19 maja 2026 zaktualizowane przez: GlaxoSmithKline
Czteroczęściowe, randomizowane, podwójnie zaślepione (części 1, 2A, 3 i 4), wieloośrodkowe, kontrolowane placebo badanie oceniające bezpieczeństwo, tolerancję, farmakokinetykę i farmakodynamikę GSK3965193 w monoterapii u zdrowych uczestników i osób żyjących z przewlekłe zapalenie wątroby typu B; i GSK3965193 w połączeniu z bepirowirenem u uczestników żyjących z przewlekłym zakażeniem wirusem zapalenia wątroby typu B
To wieloczęściowe badanie fazy 1/2a jest pierwszym badaniem z udziałem ludzi (FTIH), którego celem jest ocena bezpieczeństwa, tolerancji i farmakokinetyki (PK) dawki pojedynczej (część 1) i dawek wielokrotnych (część 2) GSK3965193 w zdrowych uczestników.
Część 3 oceni zdolność GSK3965193 do obniżenia poziomu antygenu powierzchniowego wirusa zapalenia wątroby typu B (HBsAg) u uczestników żyjących z przewlekłym zakażeniem wirusem zapalenia wątroby typu B (PLWCHB).
W części 4 zostanie ocenione bezpieczeństwo i tolerancja terapii skojarzonej GSK3965193 i bepirowirsenem oraz możliwość uzyskania trwałej odpowiedzi wirusologicznej w PLWCHB.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
74
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
-
Grenoble, Francja, 38043
- GSK Investigational Site
-
Nantes, Francja, 44000
- GSK Investigational Site
-
Rennes, Francja, 35033
- GSK Investigational Site
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 4Z6
- GSK Investigational Site
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1H 8L6
- GSK Investigational Site
-
-
-
-
-
Daegu, Korea Południowa, 41944
- GSK Investigational Site
-
Pusan, Korea Południowa, 49241
- GSK Investigational Site
-
Seoul, Korea Południowa, 05505
- GSK Investigational Site
-
-
-
-
-
Bangkok, Tajlandia, 10330
- GSK Investigational Site
-
-
-
-
-
Milan, Włochy, 20122
- GSK Investigational Site
-
Monza MB, Włochy, 20900
- GSK Investigational Site
-
-
-
-
-
Cambridge, Zjednoczone Królestwo, CB2 2GG
- GSK Investigational Site
-
London, Zjednoczone Królestwo, SW17 0QT
- GSK Investigational Site
-
London, Zjednoczone Królestwo, W2 1NY
- GSK Investigational Site
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 65 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Tak
Opis
Kryteria przyjęcia:
- Część 1 i 2: Uczestnicy w wieku od 18 do 55 lat włącznie, w momencie podpisania świadomej zgody.
- Część 3 i 4: Uczestnicy w wieku od 18 do 65 lat włącznie, w momencie podpisania świadomej zgody.
- Masa ciała >=50 kilogramów (kg) i wskaźnik masy ciała w przedziale 18-32 kilogramów na metr kwadratowy (kg/m^2) (włącznie).
- Uczestnik płci męskiej lub żeńskiej: a. Część 1 i 2: wyłącznie kobiety niemogące zajść w ciążę. b. Część 3 i 4: kobieta w wieku rozrodczym lub kobieta w wieku rozrodczym, która nie jest w ciąży ani nie karmi piersią i stosuje wysoce skuteczną metodę antykoncepcji.
- Zdolny do wyrażenia świadomej zgody podpisanej.
- Dodatkowe kryteria włączenia dla PLWCHB (części 3 i 4).
- Uczestnicy, u których udokumentowano przewlekłe zakażenie wirusem zapalenia wątroby typu B (HBV) >=6 miesięcy przed badaniem przesiewowym.
- Uczestnicy aktualnie otrzymujący stabilną terapię NA (np. dizoproksyl tenofowiru, alafenamid tenofowiru, entekawir).
- Stężenie HBsAg w osoczu lub surowicy >100 IU/ml.
- Stężenie kwasu dezoksyrybonukleinowego (DNA) HBV w osoczu lub surowicy
- E-antygen wirusa zapalenia wątroby typu B (HBeAg) dodatni lub ujemny.
- Aminotransferaza alaninowa (ALT)
Kryteria wyłączenia:
- Kryteria wykluczenia dla zdrowych uczestników:
- Dodatnie przeciwciała przeciwko wirusowi zapalenia wątroby typu A (HAV Ab immunoglobulina M [IgM]) lub dodatnie w kierunku HBV, wirusa zapalenia wątroby typu C (HCV) lub ludzkiego wirusa niedoboru odporności (HIV) podczas badania przesiewowego.
- AlAT >1 razy GGN.
- Bilirubina >1,5-krotności GGN (bilirubina izolowana >1,5-krotności GGN jest dopuszczalna, jeśli bilirubina jest frakcjonowana, a bilirubina bezpośrednia
- Skorygowany odstęp QT (QTc) >450 milisekund (ms).
- Oznaki i objawy sugerujące chorobę wywołaną przez koronawirusa 2019 (COVID-19).
- Uczestnicy ze znanymi pozytywnymi kontaktami z COVID-19 w ciągu ostatnich 14 dni.
- Dla uczestników Części 2A: Osobista historia lub rodzinna historia neuropatii obwodowej. II. Wynik >=4 w systemie punktacji klinicznej Toronto dla polineuropatii.
- Obecne lub wcześniejsze używanie wyrobów zawierających tytoń lub nikotynę (na przykład (np.) papierosów, plastrów nikotynowych lub urządzeń elektronicznych) w ciągu 6 miesięcy przed badaniem przesiewowym i/lub historia palenia papierosów > 5 paczkolat.
- Kryteria wykluczenia dla PLWCHB:
- Klinicznie istotne nieprawidłowości w historii choroby, poza przewlekłym zakażeniem HBV.
- Współistniejące lub przebyte zakażenie HCV, HIV lub wirusem zapalenia wątroby typu D (HDV).
- Historia lub podejrzenie marskości wątroby i/lub objawy marskości wątroby.
- Zdiagnozowany lub podejrzewany rak wątrobowokomórkowy.
- Historia nowotworu złośliwego w ciągu ostatnich 5 lat, z wyjątkiem określonych nowotworów, które można wyleczyć chirurgicznie (np. rak skóry).
- Zapalenie naczyń w wywiadzie lub obecność objawów podmiotowych i podmiotowych potencjalnego zapalenia naczyń [np. wysypka z zapaleniem naczyń, owrzodzenie skóry, powtarzająca się krew wykryta w moczu bez zidentyfikowanej przyczyny] lub historia/obecność innych chorób, które mogą być związane z zapaleniem naczyń (np. toczeń rumieniowaty układowy reumatoidalne zapalenie stawów, nawracające zapalenie wielochrząstkowe, zapalenie wielonerwowe).
- Zaburzenia pozawątrobowe w wywiadzie, prawdopodobnie związane z chorobami immunologicznymi HBV (np. zespół nerczycowy, kłębuszkowe zapalenie nerek dowolnego typu, guzkowe zapalenie tętnic, krioglobulinemia, niekontrolowane nadciśnienie).
- Historia nadużywania/uzależnienia od alkoholu lub narkotyków: a. Bieżące spożywanie alkoholu w ocenie badacza jako potencjalnie zakłócające przestrzeganie zasad przez uczestnika. b. Historia lub obecne nadużywanie/uzależnienie od narkotyków, według oceny badacza, jako potencjalnie zakłócające przestrzeganie zaleceń przez uczestnika.
- Historia lub inne dowody krwawienia z żylaków przełyku.
- Udokumentowana historia lub inne dowody metabolicznej choroby wątroby w ciągu 1 roku od randomizacji.
- Osobista historia lub rodzinna historia neuropatii obwodowej.
- Wynik >4 w systemie punktacji klinicznej Toronto dla polineuropatii.
- Historia otrzymywania lub obecnie otrzymywania jakiegokolwiek ogólnoustrojowego leczenia przeciwnowotworowego (w tym radioterapii) lub immunomodulującego (w tym ogólnoustrojowych doustnych kortykosteroidów, interferonu lub pegylowanego interferonu) w ciągu 8 tygodni poprzedzających pierwszą dawkę badanego leku lub oczekiwanie, że takie leczenie będą potrzebne w każdym momencie nauki.
- Nieprawidłowy i klinicznie istotny wynik 12-odprowadzeniowego EKG.
- Obecnie przyjmuje lub przyjmował w ciągu 3 miesięcy od badań przesiewowych jakiekolwiek leki immunosupresyjne (np. prednizon), inne niż krótki cykl terapii (
- Uczestnicy wymagający terapii przeciwzakrzepowej.
- Wcześniejsze leczenie jakimkolwiek oligonukleotydem lub małym interferującym RNA (siRNA) w ciągu 12 miesięcy przed pierwszym dniem dawkowania.
- Pozytywny test na zakażenie COVID-19.
- Uczestnicy ze znanymi pozytywnymi kontaktami z COVID-19 w ciągu ostatnich 14 dni.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Placebo to match GSK3965193 was administered
|
|
Komparator placebo: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
|
Placebo to match GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
|
|
Komparator placebo: 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.
|
Placebo to match GSK3965193 was administered
Bepirovirsen was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Bepirovirsen was administered
|
|
Eksperymentalny: 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.
|
Placebo to match GSK3965193 was administered
Bepirovirsen was administered
|
|
Eksperymentalny: 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.
|
GSK3965193 was administered
Bepirovirsen was administered
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Dyrektor Studium: GSK Clinical Trials, GlaxoSmithKline
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
14 kwietnia 2022
Zakończenie podstawowe (Rzeczywisty)
19 maja 2025
Ukończenie studiów (Rzeczywisty)
8 kwietnia 2026
Daty rejestracji na studia
Pierwszy przesłany
8 kwietnia 2022
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 kwietnia 2022
Pierwszy wysłany (Rzeczywisty)
15 kwietnia 2022
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 czerwca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
19 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
- Infekcje przenoszone przez krew
- Procesy patologiczne
- Przewlekła choroba
- Atrybuty choroby
- Infekcje
- Choroby wirusowe
- Choroby Układu Pokarmowego
- Choroby wątroby
- Zapalenie wątroby, wirusowe, ludzkie
- Choroby zakaźne
- Infekcje wirusami DNA
- Infekcje Hepadnaviridae
- Zapalenie wątroby, przewlekłe
- Zapalenie wątroby
- Stany patologiczne, oznaki i objawy
- Zapalenie wątroby typu B
- Wirusowe zapalenie wątroby typu B, przewlekłe
Inne numery identyfikacyjne badania
- 214760
- 2021-005117-13 (Numer EudraCT)
- 2023-509684-24 (Inny identyfikator: EU CTR)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
IChP dla tego badania zostanie udostępniona za pośrednictwem witryny Clinical Study Data Request.
Ramy czasowe udostępniania IPD
IChP zostanie udostępniona w ciągu 6 miesięcy od opublikowania wyników pierwszorzędowych punktów końcowych, kluczowych drugorzędowych punktów końcowych oraz danych dotyczących bezpieczeństwa badania.
Kryteria dostępu do udostępniania IPD
Dostęp jest udzielany po złożeniu wniosku badawczego i uzyskaniu zatwierdzenia przez niezależny panel kontrolny oraz po zawarciu umowy o udostępnianiu danych.
Dostęp jest udzielany na początkowy okres 12 miesięcy, ale w uzasadnionych przypadkach może zostać przedłużony o kolejne 12 miesięcy.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .