Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Hepatitis B Clinical Trial

Official title:

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04954859
• Other study ID #: 206882
• Status: Recruiting
• Phase: Phase 2
• Start date: November 25, 2021
• Est. completion date: October 11, 2029

Study information

• Verified date: October 2023
• Source: GlaxoSmithKline
• Contact: US GSK Clinical Trials Call Center
• Phone: 877-379-3718
• Email: GSKClinicalSupportHD[@]gsk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: October 11, 2029
• Est. primary completion date: October 11, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Participants who have previously received at least one dose of GSK3228836 and

1. Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR

2. Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study

• Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule.

• Capable of giving signed informed consent.

Exclusion Criteria:

• Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836.

• Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• GSK3228836
No study drug will be administered in this study. Eligible participants who received prior treatment with GSK3228836 in the parent studies will be included.

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Buenos Aires
Bulgaria	GSK Investigational Site	Sliven
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Calgary	Alberta
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Victoria	British Columbia
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Beijing
China	GSK Investigational Site	Changchun	Jilin
China	GSK Investigational Site	Guangzhou
China	GSK Investigational Site	Hangzhou
China	GSK Investigational Site	Shanghai
China	GSK Investigational Site	Wuhan	Hubei
France	GSK Investigational Site	Clichy
France	GSK Investigational Site	Strasbourg
Hong Kong	GSK Investigational Site	Pokfulam
Italy	GSK Investigational Site	Baggiovara (MO)	Emilia-Romagna
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Japan	GSK Investigational Site	Ehime
Japan	GSK Investigational Site	Gifu
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Hiroshima
Japan	GSK Investigational Site	Ishikawa
Japan	GSK Investigational Site	Kagawa
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Kumamoto
Japan	GSK Investigational Site	Miyagi
Japan	GSK Investigational Site	Nagasaki
Japan	GSK Investigational Site	Osaka
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Busan
Korea, Republic of	GSK Investigational Site	Gyeonggi-do
Korea, Republic of	GSK Investigational Site	Incheon
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Ulsan
Malaysia	GSK Investigational Site	Kuala Lumpur
Poland	GSK Investigational Site	Lancut
Poland	GSK Investigational Site	Lublin
Romania	GSK Investigational Site	Craiova
Romania	GSK Investigational Site	Galati
Russian Federation	GSK Investigational Site	Barnaul
Russian Federation	GSK Investigational Site	Chelyabinsk
Russian Federation	GSK Investigational Site	Krasnojarsk
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Novosibirsk
Russian Federation	GSK Investigational Site	Saint-Petersburg
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
South Africa	GSK Investigational Site	Durban
South Africa	GSK Investigational Site	Ennerdale	Gauteng
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Santander
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Bangkok
Thailand	GSK Investigational Site	Chiang Mai
Thailand	GSK Investigational Site	Hat Yai
Thailand	GSK Investigational Site	Phitsanulok
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Plymouth
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Detroit	Michigan
United States	GSK Investigational Site	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  China,  France,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Poland,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants	NA indicates Nucleos(t)ide analogue (NA)	From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33)
Primary	Time from NA cessation to the loss of SVR-NA controlled participants		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to the first occurrence of hepatitis B surface antigen (HBsAg) reversion or first use of any rescue medication- NA controlled participants		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to NA retreatment- NA controlled participants		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR- NA controlled participants		From primary endpoint assessment in the previous GSK 3228836 study up to End of Study (Month 33)
Secondary	Percentage of participants with delayed SVR in absence of rescue medication after the end of parent study- NA naïve participants		Months 0, 3, 9, 15, 21, 27, 33
Secondary	Time to the loss of SVR from time of achieving delayed SVR (NA naïve participants achieving delayed SVR)		From date of achieving SVR up to End of Study (Month 33)
Secondary	Percentage of participants with delayed SVR in the absence of any rescue medication after end of the parent study (NA controlled participants continuing NA treatment)		Months 0, 2.5, 9, 15, 21, 27, 33
Secondary	Time to the loss of SVR from time of achieving delayed SVR (NA controlled participants continuing NA treatment)		From date of achieving SVR up to End of Study (Month 33)
Secondary	Percentage of participants with delayed SVR, in the absence of NA retreatment after NA cessation (NA controlled participants who have discontinued NA treatment)		Months 6, 9, 15, 21, 27, 33
Secondary	Time to the loss of SVR from time of achieving SVR (NA controlled participants who have discontinued NA treatment)		From date of achieving SVR up to End of Study (Month 33)
Secondary	Percentage of participants with HBsAg loss in the absence of any rescue medication after NA cessation- NA controlled participants with partial response		Months 6, 9, 15, 21, 27, 33
Secondary	Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication- NA controlled participants with partial response		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication- NA controlled participants with partial response		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Time from NA cessation to the first occurrence of NA retreatment- NA controlled participants with partial response		From Visit 3 (Month 3) up to End of Study (Month 33)
Secondary	Percentage of participants with anti-HBs (antibody to HBsAg)		Up to 33 months
Secondary	Percentage of participants with anti-HBe (antibody to HBeAg)		Up to 33 months
Secondary	Absolute values for HbsAg, hepatitis B virus (HBV) DNA, hepatitis B e-antigen (HbeAg) (logarithm to the base 10 [log10] International units per milliliter [IU/mL])		Up to 33 months
Secondary	Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL)		Baseline and up to 33 months
Secondary	Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])		Up to 33 months
Secondary	Change from Baseline for HbcrAg (kU/mL)		Baseline and up to 33 months
Secondary	Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)		Up to 33 months
Secondary	Change from Baseline for HBV RNA (log10 IU/ml)		Baseline and up to 33 months
Secondary	Percentage of participants with mutations		Up to 33 months