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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04954859
• Collaborator: (none)
• Enrollment: 450
• Locations: 41
• Arms: 2
• Anticipated Duration (Months): 61.2
• Patients Per Site: 11
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B	Drug: GSK3228836	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Nov 25, 2021
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nucleos(t)ide analogue (NA) naïve participants Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study.	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.
Experimental: NA controlled participants Participants who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods. NA cessation at 3 months. No study treatment will be administered in this study.	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.

Outcome Measures

Primary Outcome Measures

1. 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 [From primary endpoint assessment in the previous GSK3228836 study up to End of Study (Month 33)]

   NA indicates Nucleos(t)ide analogue (NA)

2. 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 Outcome Measures

1. 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)]

2. 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)]

3. 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)]

4. Time from NA cessation to NA retreatment- NA controlled participants [From Visit 3 (Month 3) up to End of Study (Month 33)]

5. 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)]

6. 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]

7. 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)]

8. 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]

9. 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)]

10. 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]

11. 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)]

12. 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]

13. 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)]

14. 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)]

15. 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)]

16. Percentage of participants with anti-HBs (antibody to HBsAg) [Up to 33 months]

17. Percentage of participants with anti-HBe (antibody to HBeAg) [Up to 33 months]

18. 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]

19. Change from Baseline for HbsAg, HBV DNA, HbeAg (log10 IU/mL) [Baseline and up to 33 months]

20. Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL]) [Up to 33 months]

21. Change from Baseline for HbcrAg (kU/mL) [Baseline and up to 33 months]

22. Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml) [Up to 33 months]

23. Change from Baseline for HBV RNA (log10 IU/ml) [Baseline and up to 33 months]

24. Percentage of participants with mutations [Up to 33 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires	Argentina	C1181ACH
2	GSK Investigational Site	Sliven		Bulgaria	8800
3	GSK Investigational Site	Sofia		Bulgaria	1431
4	GSK Investigational Site	Victoria	British Columbia	Canada	V8R 6R3
5	GSK Investigational Site	Toronto	Ontario	Canada	M5G 2C4
6	GSK Investigational Site	Wuhan	Hubei	China	430030
7	GSK Investigational Site	Shanghai		China	200025
8	GSK Investigational Site	Clichy		France	92110
9	GSK Investigational Site	Strasbourg		France	67200
10	GSK Investigational Site	Pokfulam		Hong Kong
11	GSK Investigational Site	Milano	Lombardia	Italy	20157
12	GSK Investigational Site	Ehime		Japan	790-8524
13	GSK Investigational Site	Hiroshima		Japan	730-8619
14	GSK Investigational Site	Hiroshima		Japan	734-8551
15	GSK Investigational Site	Ishikawa		Japan	920-8650
16	GSK Investigational Site	Kagawa		Japan	760-8557
17	GSK Investigational Site	Kumamoto		Japan	862-8655
18	GSK Investigational Site	Miyagi		Japan	980-8574
19	GSK Investigational Site	Osaka		Japan	565-0871
20	GSK Investigational Site	Tokyo		Japan	113-8603
21	GSK Investigational Site	Tokyo		Japan	180-8610
22	GSK Investigational Site	Busan		Korea, Republic of	47392
23	GSK Investigational Site	Busan		Korea, Republic of	49241
24	GSK Investigational Site	Gyeonggi-do		Korea, Republic of	15355
25	GSK Investigational Site	Seoul		Korea, Republic of	05505
26	GSK Investigational Site	Lancut		Poland	37-100
27	GSK Investigational Site	Craiova		Romania	417307
28	GSK Investigational Site	Galati		Romania	800179
29	GSK Investigational Site	Chelyabinsk		Russian Federation	454052
30	GSK Investigational Site	Krasnojarsk		Russian Federation	660049
31	GSK Investigational Site	Moscow		Russian Federation	121170
32	GSK Investigational Site	Novosibirsk		Russian Federation	630099
33	GSK Investigational Site	Saint-Petersburg		Russian Federation	191167
34	GSK Investigational Site	Singapore		Singapore	119074
35	GSK Investigational Site	Singapore		Singapore	529889
36	GSK Investigational Site	Ennerdale	Gauteng	South Africa	1830
37	GSK Investigational Site	Durban		South Africa	4091
38	GSK Investigational Site	Bangkok		Thailand	10400
39	GSK Investigational Site	Hat Yai		Thailand	90110
40	GSK Investigational Site	London		United Kingdom	WC1E 6JB
41	GSK Investigational Site	Plymouth		United Kingdom	PL68DH

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04954859
• Other Study ID Numbers: 206882
• First Posted: Jul 8, 2021
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: GSK3228836; B-Sure; Nucleos(t)ide; Sustained virologic response; durability
• Additional relevant MeSH terms: Hepatitis B; Hepatitis

Study Results

No Results Posted as of Jul 29, 2022