Estudio prospectivo multicéntrico (B-Sure) para evaluar la durabilidad a largo plazo de la respuesta al tratamiento en participantes con hepatitis B crónica con y sin terapia con análogos de nucleós(t)idos que hayan participado en un estudio previo de tratamiento con bepirovirsen

ReclutandoFase 2ClinicalTrials.gov

ID: NCT04954859Tipo: INTERVENTIONALInicio: 14 de dic de 2021Fin estimado: 8 de feb de 2029

Gastroenterología Enfermedades Infecciosas

Resumen

Se trata de un estudio de seguimiento multicéntrico global a largo plazo para evaluar la durabilidad de la eficacia, medida por el mantenimiento de la respuesta al tratamiento del estudio original, en participantes que participaron en un estudio previo con bepirovirsen y lograron una respuesta completa o parcial. Los participantes elegibles serán incluidos en este estudio tras completar la visita de fin de estudio (FDE) en los respectivos estudios originales con bepirovirsen (estudios B-Clear [209668: NCT04449029], B-Together [209348: NCT04676724], B-Fine [212602: NCT04544956], B-Well 1 [202009: NCT05630807], B-Well 2 [219288: NCT05630820] y TH HBV ASO-001 [217023: NCT05276297]). Los participantes serán categorizados como Sin-AN, AN-cesado o Con-AN según su estado con el análogo de nucleós(t)ido (AN) en el estudio original. No se administrará ningún tratamiento adicional con bepirovirsen en este estudio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
Capable of giving informed consent.
For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
Participants who have previously received at least one dose of bepirovirsen AND
Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR
Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (\<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
NA cessated at Week 48 in parent study and achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at the EOS visit (Week 96) in the parent study OR
Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study OR
Did not achieve NA cessation criteria in parent study but achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study.
For participants rolling over from 217023 (TH HBV ASO-001):
Participants who have previously received at least 1 dose of bepirovirsen AND
Achieved HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg \< 1 IU/ml and HBV DNA \<LLOQ, at the EOS study visit \[Week 133 ASO12 arm), or Week 145 (ASO24 arm)\] in parent study OR
Did not achieve HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg \< 1 IU/ml and HBV DNA \< LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) in the parent study.

Criterios de exclusión

Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Intervenciones

drug

Bepirovirsen

No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.

drug

Placebo

No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

US GSK Clinical Trials Call Center · GSKClinicalSupportHD@gsk.com · 877-379-3718

RECRUITING

Patrocinadores

PrincipalGlaxoSmithKline

Contactos

US GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com 877-379-3718

EU GSK Clinical Trials Call Center

CONTACT

GSKClinicalSupportHD@gsk.com +44 (0) 20 89904466

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Estudio prospectivo multicéntrico (B-Sure) para evaluar l... | EligiMed