Studie av GSK3965193 i friske deltakere og alene og i kombinasjon med Bepirovirsen hos deltakere som lever med kronisk hepatitt B-infeksjon
19. mai 2026 oppdatert av: GlaxoSmithKline
Firedelt, randomisert, dobbeltblind (del 1, 2A, 3 og 4), multisenter, placebokontrollert studie for å vurdere sikkerheten, tolerabiliteten, farmakokinetikken og farmakodynamikken til GSK3965193 monoterapi hos friske deltakere og hos deltakere som lever med Kronisk hepatitt B-infeksjon; og GSK3965193 i kombinasjon med Bepirovirsen hos deltakere som lever med kronisk hepatitt B-infeksjon
Denne fase 1/2a flerdelte studien er en førstegangs-i-menneske (FTIH)-studie designet for å evaluere sikkerheten, tolerabiliteten og farmakokinetikken (PK) til enkeltdoser (del 1) og gjentatte doser (del 2) av GSK3965193 i friske deltakere.
Del 3 vil evaluere evnen til GSK3965193 til å senke hepatitt B-virusoverflateantigen (HBsAg) hos deltakere som lever med kronisk hepatitt B-infeksjon (PLWCHB).
Del 4 vil evaluere sikkerheten og toleransen til kombinasjonsbehandling med GSK3965193 og bepirovirsen og potensialet for å påvirke vedvarende virologisk respons i PLWCHB.
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
74
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 4Z6
- GSK Investigational Site
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- GSK Investigational Site
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Grenoble, Frankrike, 38043
- GSK Investigational Site
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Nantes, Frankrike, 44000
- GSK Investigational Site
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Rennes, Frankrike, 35033
- GSK Investigational Site
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Milan, Italia, 20122
- GSK Investigational Site
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Monza MB, Italia, 20900
- GSK Investigational Site
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Cambridge, Storbritannia, CB2 2GG
- GSK Investigational Site
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London, Storbritannia, SW17 0QT
- GSK Investigational Site
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London, Storbritannia, W2 1NY
- GSK Investigational Site
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Daegu, Sør -Korea, 41944
- GSK Investigational Site
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Pusan, Sør -Korea, 49241
- GSK Investigational Site
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Seoul, Sør -Korea, 05505
- GSK Investigational Site
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Bangkok, Thailand, 10330
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Beskrivelse
Inklusjonskriterier:
- Del 1 og 2: Deltakere mellom 18 og 55 år inkludert, på tidspunktet for signering av det informerte samtykket.
- Del 3 og 4: Deltakere mellom 18 og 65 år inklusive, på tidspunktet for undertegning av informert samtykke.
- Kroppsvekt >=50 kilogram (kg) og kroppsmasseindeks innenfor området 18-32 kilogram per kvadratmeter (kg/m^2) (inklusive).
- Mannlig eller kvinnelig deltaker: a. Del 1 og 2: Kun kvinne i ikke-fertil alder. b. Del 3 og 4: kvinne i ikke-fertil alder eller kvinne i fertil alder som ikke er gravid eller ammer og bruker en prevensjonsmetode som er svært effektiv.
- I stand til å gi signert informert samtykke.
- Ytterligere inkluderingskriterier for PLWCHB (del 3 og 4).
- Deltakere som har dokumentert kronisk hepatitt B-virus (HBV) infeksjon >=6 måneder før screening.
- Deltakere som for tiden mottar stabil NA-behandling (f.eks. tenofovirdisoproksil, tenofoviralafenamid, entecavir).
- Plasma- eller serum-HBsAg-konsentrasjon >100 IE/ml.
- Plasma eller serum HBV deoksyribonukleinsyre (DNA) konsentrasjon
- Hepatitt B-virus e-antigen (HBeAg) positivt eller negativt.
- Alaninaminotransferase (ALT)
Ekskluderingskriterier:
- Ekskluderingskriterier for friske deltakere:
- Positivt hepatitt A-virusantistoff (HAV Ab immunoglobulin M [IgM]), eller positivt for HBV, hepatitt C-virus (HCV) eller humant immunsviktvirus (HIV) ved screening.
- ALT >1 ganger ULN.
- Bilirubin >1,5 ganger ULN (isolert bilirubin >1,5 ganger ULN er akseptabelt hvis bilirubin er fraksjonert og direkte bilirubin
- Korrigert QT-intervall (QTc) >450 millisekunder (ms).
- Tegn og symptomer som tyder på Coronavirus Disease 2019 (COVID-19).
- Deltakere med kjente covid-19 positive kontakter de siste 14 dagene.
- For deltakere i del 2A: i. Personlig historie eller familiehistorie med perifer nevropati. ii. En skåre >=4 på Torontos kliniske scoringssystem for polynevropati.
- Nåværende eller tidligere bruk av tobakks- eller nikotinholdige produkter (for eksempel (f.eks.) sigaretter, nikotinplaster eller elektroniske enheter) innen 6 måneder før screening og/eller har en røykepakkehistorie på >5 pakkeår.
- Ekskluderingskriterier for PLWCHB:
- Klinisk signifikante abnormiteter i sykehistorien, bortsett fra kronisk HBV-infeksjon.
- Samtidig infeksjon med eller tidligere historie med HCV, HIV eller Hepatitt D-virus (HDV).
- Anamnese med eller mistenkt levercirrhose og/eller tegn på skrumplever.
- Diagnostisert eller mistenkt hepatocellulært karsinom.
- Anamnese med malignitet de siste 5 årene med unntak av spesifikke kreftformer som er kurert ved kirurgisk reseksjon (f.eks. hudkreft).
- Anamnese med vaskulitt eller tilstedeværelse av symptomer og tegn på potensiell vaskulitt [f.eks. vaskulittisk utslett, hudsår, gjentatt blod påvist i urin uten identifisert årsak] eller historie/tilstedeværelse av andre sykdommer som kan være assosiert med vaskulitttilstand (f.eks. systemisk lupus erythematosus) , revmatoid artritt, residiverende polykondritis, mononeuritt multipleks).
- Anamnese med ekstrahepatiske lidelser muligens relatert til HBV-immuntilstander (f.eks. nefrotisk syndrom, alle typer glomerulonefritt, polyarteritis nodosa, kryoglobulinemi, ukontrollert hypertensjon).
- Historie med alkohol- eller narkotikamisbruk/avhengighet: a. Nåværende alkoholbruk som etterforskeren har bedømt til å potensielt forstyrre deltakerens etterlevelse. b. Historie om eller nåværende narkotikamisbruk/avhengighet som vurderes av etterforskeren å potensielt forstyrre deltakerens etterlevelse.
- Anamnese eller andre tegn på blødning fra esophageal varicer.
- Dokumentert historie eller andre bevis på metabolsk leversykdom innen 1 år etter randomisering.
- Personlig historie eller familiehistorie med perifer nevropati.
- En skåre >4 på Torontos kliniske scoringssystem for polynevropati.
- Anamnese med å ha mottatt eller for tiden mottatt systemisk antineoplastisk (inkludert stråling) eller immunmodulerende behandling (inkludert systemiske orale kortikosteroider, interferon eller pegylert interferon) i løpet av de 8 ukene før den første dosen av studiemedikamentet eller forventning om at slik behandling vil være nødvendig når som helst under studiet.
- Unormalt og klinisk signifikant 12-avlednings EKG-funn.
- Tar for tiden, eller tas innen 3 måneder etter screening, alle immundempende legemidler (f.eks. prednison), bortsett fra et kort behandlingsforløp (
- Deltakere som trenger anti-koagulasjonsterapi.
- Tidligere behandling med ethvert oligonukleotid eller lite interfererende RNA (siRNA) innen 12 måneder før den første doseringsdagen.
- Positiv test for covid-19-infeksjon.
- Deltakere med kjente covid-19 positive kontakter de siste 14 dagene.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Placebo to match GSK3965193 was administered
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Placebo komparator: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
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Placebo to match GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
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Eksperimentell: 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.
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GSK3965193 was administered
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Placebo komparator: 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.
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Placebo to match GSK3965193 was administered
Bepirovirsen was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Bepirovirsen was administered
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Eksperimentell: 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.
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Placebo to match GSK3965193 was administered
Bepirovirsen was administered
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Eksperimentell: 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.
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GSK3965193 was administered
Bepirovirsen was administered
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Tidsramme: From the start of study intervention (Day 1) up to 12 weeks
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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.
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From the start of study intervention (Day 1) up to 12 weeks
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Part 2A: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Tidsramme: From the start of study intervention (Day 1) up to 6 weeks
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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.
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From the start of study intervention (Day 1) up to 6 weeks
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Part 2B: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Tidsramme: From the start of study intervention (Day 1) up to 9 weeks
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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.
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From the start of study intervention (Day 1) up to 9 weeks
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Part 3: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Tidsramme: From the start of study intervention (Day 1) up to 6 weeks
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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.
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From the start of study intervention (Day 1) up to 6 weeks
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Part 4: Number of Participants With TEAEs, STEAEs, and Treatment Withdrawals Due to TEAEs
Tidsramme: From the start of study intervention (Day 1) up to 48 weeks
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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.
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From the start of study intervention (Day 1) up to 48 weeks
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Part 1: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Tidsramme: At Day 2
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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.
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At Day 2
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Part 2A: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Tidsramme: Up to 21 days
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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.
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Up to 21 days
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Part 2B: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Tidsramme: Up to 9 weeks
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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.
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Up to 9 weeks
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Part 3: Number of Participants With Clinically Significant Hematology and Clinical Chemistry Parameters
Tidsramme: Up to 35 days
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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.
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Up to 35 days
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Part 3: Number of Participants With Clinically Significant Urinalysis Parameters
Tidsramme: Up to 28 days
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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.
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Up to 28 days
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Part 4: Number of Participants With Clinically Significant Hematology, Clinical Chemistry, and Urinalysis Parameters
Tidsramme: Up to 48 weeks
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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.
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Up to 48 weeks
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Part 1: Number of Participants With Clinically Significant Vital Sign Findings
Tidsramme: Up to 12 weeks
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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.
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Up to 12 weeks
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Part 2A: Number of Participants With Clinically Significant Vital Sign Findings
Tidsramme: Up to 21 days
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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.
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Up to 21 days
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Part 2B: Number of Participants With Clinically Significant Vital Sign Findings
Tidsramme: Up to 9 weeks
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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.
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Up to 9 weeks
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Part 3: Number of Participants With Clinically Significant Vital Sign Findings
Tidsramme: Up to 35 days
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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.
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Up to 35 days
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Part 4: Number of Participants With Clinically Significant Vital Signs Findings
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: GSK Clinical Trials, GlaxoSmithKline
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. april 2022
Primær fullføring (Faktiske)
19. mai 2025
Studiet fullført (Faktiske)
8. april 2026
Datoer for studieregistrering
Først innsendt
8. april 2022
Først innsendt som oppfylte QC-kriteriene
8. april 2022
Først lagt ut (Faktiske)
15. april 2022
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Blodbårne infeksjoner
- Patologiske prosesser
- Kronisk sykdom
- Sykdomsattributter
- Infeksjoner
- Virussykdommer
- Sykdommer i fordøyelsessystemet
- Leversykdommer
- Hepatitt, viral, menneskelig
- Smittsomme sykdommer
- DNA-virusinfeksjoner
- Hepadnaviridae-infeksjoner
- Hepatitt, kronisk
- Hepatitt
- Patologiske tilstander, tegn og symptomer
- Hepatitt B
- Hepatitt B, kronisk
Andre studie-ID-numre
- 214760
- 2021-005117-13 (EudraCT-nummer)
- 2023-509684-24 (Annen identifikator: EU CTR)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
IPD for denne studien vil bli gjort tilgjengelig via nettstedet for forespørsel om kliniske studier.
IPD-delingstidsramme
IPD vil bli gjort tilgjengelig innen 6 måneder etter publisering av resultatene av de primære endepunktene, et viktig sekundært endepunkt og sikkerhetsdata for studien.
Tilgangskriterier for IPD-deling
Tilgang gis etter at et forskningsforslag er sendt inn og har mottatt godkjenning fra det uavhengige granskingspanelet og etter at en datadelingsavtale er på plass.
Tilgang gis for en innledende periode på 12 måneder, men en forlengelse kan gis, når det er berettiget, i inntil ytterligere 12 måneder.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .