Fact CheckerSign in

NCT06537414Active, not recruitingPhase 2

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

A Phase 2b, Multi-centre, Randomized, Partially Placebo-controlled, Double-blind Study to Investigate the Safety and Efficacy of Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen in Participants With Chronic Hepatitis B Virus on Background Nucleos(t)Ide Analogue Therapy (B-United)

Source: ClinicalTrials.gov · Last updated 7 Jul 2026

Brief summary (registry, in English)

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen. The study will also include an optional long-term follow-up (LTFU) extension stage for eligible participants.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
283 (actual)
First submitted
1 Aug 2024
Start date
11 Nov 2024
Primary completion date
31 May 2027
Lead sponsor
GlaxoSmithKline
Diseases
Hepatitis B
NCT number
NCT06537414
EU CT number
2024-514507-33-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 283
  • From 11 Nov 2024 to the primary completion date, 31 May 2027
  • 68 sites in 19 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently taking, or took within 3 months of screening, any immunosuppressing drugs (example, prednisone), other than a short course of therapy (\<=2 weeks) or topical/inhaled steroid use.
  • Participants, to whom immunosuppressive treatment (including therapeutic doses of steroids) is contraindicated, should not be considered for enrollment in the study.
  • Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy.
  • Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering RNA (siRNA).
  • Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day.

Other illness

  • Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings.
  • Coinfection with Hepatitis C (cured \<12 months at the time of screening), Human immunodeficiency virus or hepatitis D virus
  • History of or suspected liver cirrhosis and/or evidence of cirrhosis.
  • History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (example, skin cancer). Participants under evaluation for possible malignancy are not eligible.
  • History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
  • History of extrahepatic disorders possibly related to HBV immune conditions (example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
  • History of alcohol or drug abuse/dependence:
  • History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation
  • Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection.

Lab values

  • Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted.
  • Fridericia's QT correction formula (QTcF) \>=450 millisecond (msec) (if single electrocardiogram \[ECG\] at screening shows QTcF \>=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).

Other

  • Diagnosed or suspected hepatocellular carcinoma.

Who the study is looking for

  • Age: At least 18 years of age at the time of signing the informed consent
  • Documented chronic HBV infection greater than or equal to (\>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study.
  • Plasma or serum HBsAg concentration greater than (\>) 100 international units per milliliter (IU/mL)
  • Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA less than (\<) 90 IU/mL
  • Alanine aminotransferase less than or equal to (\<=) 2\* upper limit of normal (ULN)
  • Participants who are willing and able to cease their NA treatment in accordance with the protocol.
  • Male and Female

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (68)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
-
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
-
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
-
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
-
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
-
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
-
Coordinator of this site? Confirm its status
AracajuBrazilUnknown status
-
Coordinator of this site? Confirm its status
CuritibaBrazilUnknown status
-
Coordinator of this site? Confirm its status
ManausBrazilUnknown status
-
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
-
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
-
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
-
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
-
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
-
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
-
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
-
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
-
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
-
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
-
Coordinator of this site? Confirm its status
HanoverGermanyUnknown status
-
Coordinator of this site? Confirm its status
MünsterGermanyUnknown status
-
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
-
Coordinator of this site? Confirm its status
LeónSpainUnknown status
-
Coordinator of this site? Confirm its status
MadridSpainUnknown status
-
Coordinator of this site? Confirm its status
SalamancaSpainUnknown status
-
Coordinator of this site? Confirm its status
SantanderSpainUnknown status
-
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
-
Coordinator of this site? Confirm its status
ClichyFranceUnknown status
-
Coordinator of this site? Confirm its status
CréteilFranceUnknown status
-
Coordinator of this site? Confirm its status
LimogesFranceUnknown status
-
Coordinator of this site? Confirm its status
LyonFranceUnknown status
-
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
-
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
MiddlesbroughUnited KingdomUnknown status
-
Coordinator of this site? Confirm its status
AthensGreeceUnknown status
-
Coordinator of this site? Confirm its status
PokfulamHong Kong SAR ChinaUnknown status
-
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaUnknown status
-
Coordinator of this site? Confirm its status
BergamoItalyUnknown status
-
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status
-
Coordinator of this site? Confirm its status
MilanItalyUnknown status
-
Coordinator of this site? Confirm its status
NaplesItalyUnknown status
-
Coordinator of this site? Confirm its status
PadovaItalyUnknown status
-
Coordinator of this site? Confirm its status
PisaItalyUnknown status
-
Coordinator of this site? Confirm its status
RomaItalyUnknown status
-
Coordinator of this site? Confirm its status
ChibaJapanUnknown status
-
Coordinator of this site? Confirm its status
HokkaidoJapanUnknown status
-
Coordinator of this site? Confirm its status
HyōgoJapanUnknown status
-
Coordinator of this site? Confirm its status
KagawaJapanUnknown status
-
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
-
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
-
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
-
Coordinator of this site? Confirm its status
YamanashiJapanUnknown status
-
Coordinator of this site? Confirm its status
AnsanSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
PusanSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
-
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
Papatoetoe AucklandNew ZealandUnknown status
-
Coordinator of this site? Confirm its status
SingaporeSingaporeUnknown status
-
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
-
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
-
Coordinator of this site? Confirm its status
Tau-YuanTaiwanUnknown status
-
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
San JoseUnited StatesUnknown status
-
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaUnknown status
-
Coordinator of this site? Confirm its status
Reiger ParkSouth AfricaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.