Studie van GSK3965193 bij gezonde deelnemers en alleen en in combinatie met bepirovirsen bij deelnemers die leven met chronische hepatitis B-infectie
19 mei 2026 bijgewerkt door: GlaxoSmithKline
Vierdelig, gerandomiseerd, dubbelblind (deel 1, 2A, 3 en 4), multicenter, placebogecontroleerd onderzoek ter beoordeling van de veiligheid, verdraagbaarheid, farmacokinetiek en farmacodynamiek van monotherapie GSK3965193 bij gezonde deelnemers en bij deelnemers die leven met Chronische Hepatitis B-infectie; en GSK3965193 in combinatie met Bepirovirsen bij deelnemers die leven met chronische hepatitis B-infectie
Dit uit meerdere delen bestaande fase 1/2a-onderzoek is een first-time-in-human (FTIH)-onderzoek dat is opgezet om de veiligheid, verdraagbaarheid en farmacokinetiek (PK) van enkelvoudige (deel 1) en herhaalde doses (deel 2) van GSK3965193 in gezonde deelnemers.
Deel 3 evalueert het vermogen van GSK3965193 om het hepatitis B-virusoppervlakte-antigeen (HBsAg) te verlagen bij deelnemers die leven met een chronische hepatitis B-infectie (PLWCHB).
Deel 4 evalueert de veiligheid en verdraagbaarheid van combinatietherapie met GSK3965193 en bepirovirsen en het potentieel om een aanhoudende virologische respons te bewerkstelligen bij PLWCHB.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
74
Fase
- Fase 2
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- GSK Investigational Site
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L6
- GSK Investigational Site
-
-
-
-
-
Grenoble, Frankrijk, 38043
- GSK Investigational Site
-
Nantes, Frankrijk, 44000
- GSK Investigational Site
-
Rennes, Frankrijk, 35033
- GSK Investigational Site
-
-
-
-
-
Milan, Italië, 20122
- GSK Investigational Site
-
Monza MB, Italië, 20900
- GSK Investigational Site
-
-
-
-
-
Bangkok, Thailand, 10330
- GSK Investigational Site
-
-
-
-
-
Cambridge, Verenigd Koninkrijk, CB2 2GG
- GSK Investigational Site
-
London, Verenigd Koninkrijk, SW17 0QT
- GSK Investigational Site
-
London, Verenigd Koninkrijk, W2 1NY
- GSK Investigational Site
-
-
-
-
-
Daegu, Zuid -Korea, 41944
- GSK Investigational Site
-
Pusan, Zuid -Korea, 49241
- GSK Investigational Site
-
Seoul, Zuid -Korea, 05505
- GSK Investigational Site
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 65 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusiecriteria:
- Deel 1 en 2: Deelnemers tussen 18 en 55 jaar oud, op het moment van ondertekening van de geïnformeerde toestemming.
- Deel 3 en 4: Deelnemers tussen 18 en 65 jaar oud, op het moment van ondertekening van de geïnformeerde toestemming.
- Lichaamsgewicht >=50 kilogram (kg) en body mass index binnen het bereik van 18-32 kilogram per vierkante meter (kg/m^2) (inclusief).
- Mannelijke of vrouwelijke deelnemer: a. Deel 1 en 2: alleen vrouwen die niet zwanger kunnen worden. b. Deel 3 en 4: vrouw die niet zwanger kan worden of vrouw die zwanger kan worden die niet zwanger is of borstvoeding geeft en een anticonceptiemethode gebruikt die zeer effectief is.
- In staat om ondertekende geïnformeerde toestemming te geven.
- Aanvullende opnamecriteria voor PLWCHB (deel 3 en 4).
- Deelnemers met een gedocumenteerde chronische infectie met het hepatitis B-virus (HBV) >=6 maanden voorafgaand aan de screening.
- Deelnemers die momenteel een stabiele NA-therapie krijgen (bijv. tenofovirdisoproxil, tenofoviralafenamide, entecavir).
- Plasma- of serum-HBsAg-concentratie >100 IE/ml.
- Plasma- of serum-HBV-deoxyribonucleïnezuur (DNA)-concentratie
- Hepatitis B-virus e-antigeen (HBeAg) positief of negatief.
- Alanine-aminotransferase (ALT)
Uitsluitingscriteria:
- Uitsluitingscriteria voor gezonde deelnemers:
- Positief antilichaam tegen hepatitis A-virus (HAV Ab-immunoglobuline M [IgM]), of positief voor HBV, hepatitis C-virus (HCV) of humaan immunodeficiëntievirus (HIV) bij screening.
- ALAT >1 maal ULN.
- Bilirubine >1,5 keer ULN (geïsoleerd bilirubine >1,5 keer ULN is acceptabel als bilirubine gefractioneerd is en direct bilirubine
- Gecorrigeerd QT-interval (QTc) >450 milliseconden (msec).
- Tekenen en symptomen die wijzen op Coronavirus Disease 2019 (COVID-19).
- Deelnemers met bekende COVID-19 positieve contacten in de afgelopen 14 dagen.
- Voor deelnemers aan Deel 2A: i. Persoonlijke geschiedenis of familiegeschiedenis van perifere neuropathie. ii. Een score >=4 op het Toronto klinische scoresysteem voor polyneuropathie.
- Huidig of eerder gebruik van tabaks- of nicotinebevattende producten (bijvoorbeeld (bijv.) sigaretten, nicotinepleisters of elektronische apparaten) binnen 6 maanden vóór de screening en/of een rookgeschiedenis van meer dan 5 pakjaren.
- Uitsluitingscriteria voor PLWCHB:
- Klinisch significante afwijkingen in de medische geschiedenis, afgezien van chronische HBV-infectie.
- Gelijktijdige infectie met of een voorgeschiedenis van HCV, HIV of Hepatitis D-virus (HDV).
- Voorgeschiedenis van of vermoedelijke levercirrose en/of tekenen van cirrose.
- Gediagnosticeerd of vermoed hepatocellulair carcinoom.
- Geschiedenis van maligniteit in de afgelopen 5 jaar, met uitzondering van specifieke kankers die worden genezen door chirurgische resectie (bijv. Huidkanker).
- Voorgeschiedenis van vasculitis of aanwezigheid van symptomen en tekenen van mogelijke vasculitis [bijv. vasculitisuitslag, huidzweren, herhaaldelijk bloed gedetecteerd in de urine zonder aanwijsbare oorzaak] of voorgeschiedenis/aanwezigheid van andere ziekten die verband kunnen houden met vasculitis (bijv. systemische lupus erythematosus). reumatoïde artritis, recidiverende polychondritis, mononeuritis multiplex).
- Voorgeschiedenis van extrahepatische aandoeningen die mogelijk verband houden met HBV-immuunaandoeningen (bijv. nefrotisch syndroom, elk type glomerulonefritis, polyarteritis nodosa, cryoglobulinemie, ongecontroleerde hypertensie).
- Geschiedenis van alcohol- of drugsmisbruik/-afhankelijkheid: Huidig alcoholgebruik, zoals beoordeeld door de onderzoeker, kan de naleving door deelnemers mogelijk verstoren. b. Voorgeschiedenis van of huidig drugsmisbruik/-afhankelijkheid, zoals beoordeeld door de onderzoeker, die mogelijk de therapietrouw van de deelnemer verstoort.
- Geschiedenis of ander bewijs van bloeding uit slokdarmspataderen.
- Gedocumenteerde geschiedenis of ander bewijs van metabole leverziekte binnen 1 jaar na randomisatie.
- Persoonlijke geschiedenis of familiegeschiedenis van perifere neuropathie.
- Een score >4 op het Toronto klinische scoresysteem voor polyneuropathie.
- Geschiedenis van het hebben ontvangen of momenteel ontvangen van een systemische antineoplastische (inclusief bestraling) of immuunmodulerende behandeling (inclusief systemische orale corticosteroïden, interferon of gepegyleerd interferon) binnen de 8 weken voorafgaand aan de eerste dosis van het onderzoeksgeneesmiddel of de verwachting dat een dergelijke behandeling zal op elk moment tijdens het onderzoek nodig zijn.
- Abnormale en klinisch significante 12-afleidingen ECG-bevinding.
- U gebruikt momenteel of binnen 3 maanden na de screening immunosuppressieve geneesmiddelen (bijv. prednison), anders dan een korte kuur (
- Deelnemers die antistollingstherapieën nodig hebben.
- Voorafgaande behandeling met een oligonucleotide of klein interfererend RNA (siRNA) binnen 12 maanden voorafgaand aan de eerste doseringsdag.
- Positieve test voor COVID-19-infectie.
- Deelnemers met bekende COVID-19 positieve contacten in de afgelopen 14 dagen.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Placebo-vergelijker: Part 2A: Placebo
Healthy participants received repeat doses of placebo oral solution twice daily (BID) for 14 days.
|
Placebo to match GSK3965193 was administered
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Placebo-vergelijker: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
|
Experimenteel: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Treatment Emergent Adverse Events (STEAEs), and Treatment Withdrawals Due to TEAEs
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Part 2B: AUC(0-inf) of GSK3965193 Following Single Dose Administration
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: GSK Clinical Trials, GlaxoSmithKline
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
14 april 2022
Primaire voltooiing (Werkelijk)
19 mei 2025
Studie voltooiing (Werkelijk)
8 april 2026
Studieregistratiedata
Eerst ingediend
8 april 2022
Eerst ingediend dat voldeed aan de QC-criteria
8 april 2022
Eerst geplaatst (Werkelijk)
15 april 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
19 mei 2026
Laatst geverifieerd
1 mei 2026
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Door bloed overgedragen infecties
- Pathologische processen
- Chronische ziekte
- Ziekte attributen
- Infecties
- Virusziekten
- Ziekten van het spijsverteringsstelsel
- Lever Ziekten
- Hepatitis, viraal, menselijk
- Overdraagbare ziekten
- DNA-virusinfecties
- Hepadnaviridae-infecties
- Hepatitis, chronisch
- Hepatitis
- Pathologische aandoeningen, tekenen en symptomen
- Hepatitis B
- Hepatitis B, chronisch
Andere studie-ID-nummers
- 214760
- 2021-005117-13 (EudraCT-nummer)
- 2023-509684-24 (Andere identificatie: EU CTR)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
IPD voor deze studie zal beschikbaar worden gesteld via de Clinical Study Data Request-site.
IPD-tijdsbestek voor delen
IPD zal beschikbaar worden gesteld binnen 6 maanden na publicatie van de resultaten van de primaire eindpunten, belangrijke secundaire eindpunten en veiligheidsgegevens van het onderzoek.
IPD-toegangscriteria voor delen
Toegang wordt verleend nadat een onderzoeksvoorstel is ingediend en is goedgekeurd door het onafhankelijke beoordelingspanel en nadat er een overeenkomst voor het delen van gegevens is gesloten.
Toegang wordt verleend voor een initiële periode van 12 maanden, maar indien gerechtvaardigd kan een verlenging worden verleend voor nog eens 12 maanden.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- ICF
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .