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Antiviral Agent

GSK3228836 for Hepatitis B (B-Clear Trial)

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 36, and 48

Summary

This trial is testing a new drug called GSK3228836 to see if it can lower hepatitis B virus levels in people with chronic hepatitis B. The study includes patients who are either not on treatment or are on stable treatment. The goal is to see if the drug can keep the virus at very low levels for several months after treatment ends.

Eligible Conditions
  • Hepatitis B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 36, and 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 36, and 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Achieving Sustained Virologic Response (SVR)
Secondary study objectives
Mean AUC0-24h of NA Therapies
Mean Area Under the Concentration-time Curve From Time 0 up to 24 Hours (AUC0-24h) of GSK3228836
Mean Change From Baseline in Anti-HBsAg Level
+18 more

Side effects data

From 2022 Phase 2 trial • 457 Patients • NCT04449029
45%
Injection site erythema
25%
Pyrexia
24%
Injection site pruritus
22%
Alanine aminotransferase increased
21%
Headache
19%
Injection site pain
16%
Injection site discolouration
15%
Injection site bruising
13%
Aspartate aminotransferase increased
10%
Fatigue
10%
Injection site induration
10%
Myalgia
10%
Rash
10%
Injection site swelling
9%
Injection site discomfort
9%
COVID-19
6%
Injection site haematoma
6%
Complement factor C3 decreased
6%
Complement factor C4 decreased
6%
Back pain
6%
Nausea
6%
Dizziness
6%
Pruritus
4%
Diarrhoea
4%
Antineutrophil cytoplasmic antibody positive
4%
Malaise
4%
Upper respiratory tract infection
4%
Urticaria
4%
Pain in extremity
4%
Abdominal pain upper
4%
Platelet count decreased
4%
Arthralgia
4%
Haematuria
4%
Oropharyngeal pain
3%
Neutropenia
3%
Abdominal pain
3%
Chills
3%
Influenza like illness
3%
Decreased appetite
3%
Flank pain
3%
Muscular weakness
3%
Erythema
3%
Pharyngitis
3%
Creatinine renal clearance decreased
3%
Injection site nodule
3%
Pain
3%
Iron deficiency anaemia
3%
Thrombocytopenia
3%
Abdominal distension
3%
Non-cardiac chest pain
3%
Herpes simplex
3%
Influenza
3%
Nasopharyngitis
3%
C-reactive protein increased
3%
Insomnia
3%
Cough
1%
Abdominal pain lower
1%
Constipation
1%
Muscle twitching
1%
Nail injury
1%
Skin abrasion
1%
Lymph node pain
1%
Thrombocytosis
1%
Abdominal discomfort
1%
Gastrointestinal sounds abnormal
1%
Feeling abnormal
1%
Hyperthermia
1%
Vaccination complication
1%
Swelling
1%
Hepatic function abnormal
1%
Blood bilirubin increased
1%
Furuncle
1%
Hepatitis B
1%
Infection
1%
Oral herpes
1%
Oral infection
1%
Complement factor abnormal
1%
Complement factor increased
1%
Protein urine present
1%
Epicondylitis
1%
Eye injury
1%
Polydipsia
1%
Joint swelling
1%
Dysgeusia
1%
Hypoaesthesia
1%
Lethargy
1%
Nephrolithiasis
1%
Adenomyosis
1%
Rhinorrhoea
1%
Petechiae
1%
Rash maculo-papular
1%
Rash pruritic
1%
COVID-19 pneumonia
1%
Coagulopathy
1%
Gastrooesophageal reflux disease
1%
Cellulitis
1%
Neoplasm skin
1%
Spinal column injury
1%
Increased tendency to bruise
1%
Atrial fibrillation
1%
Palpitations
1%
Supraventricular extrasystoles
1%
Tachycardia
1%
Eye pain
1%
Periorbital swelling
1%
Catarrh
1%
Aphthous ulcer
1%
Acne
1%
Gingival bleeding
1%
Haemorrhoidal haemorrhage
1%
Asthenia
1%
Rash macular
1%
Injection site anaesthesia
1%
Injection site warmth
1%
Gallbladder polyp
1%
Hepatitis acute
1%
Hypertransaminasaemia
1%
Food allergy
1%
Seasonal allergy
1%
Neutrophil count decreased
1%
Herpes zoster
1%
Parotitis
1%
Animal bite
1%
Contusion
1%
Sunburn
1%
Activated partial thromboplastin time prolonged
1%
Blood alkaline phosphatase increased
1%
Muscle spasms
1%
Musculoskeletal pain
1%
Musculoskeletal stiffness
1%
Osteoarthritis
1%
Leiomyoma
1%
Dysuria
1%
Dysmenorrhoea
1%
Epistaxis
1%
Dermatitis
1%
Dermatitis allergic
1%
Nail bed bleeding
1%
Umbilical erythema
1%
Hypertension
1%
Ear pain
1%
Vaginal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
GSK3228836 for 12+12 WK (Not on NA Therapy)
GSK3228836 for 12 WK + Placebo for 12 WK (on NA Therapy)
GSK3228836 for 24 WK (Not on NA Therapy)
GSK3228836 for 12 WK + Placebo for 12 WK (Not on NA Therapy)
Placebo for 12 WK + GSK3228836 for 12 WK (Not on NA Therapy)
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
GSK3228836 for 12+12 WK (on NA Therapy)

Trial Design

8Treatment groups
Experimental Treatment
Group I: Cohort 2: Placebo/ GSK3228836 300 mg + Placebo LDExperimental Treatment2 Interventions
Eligible participants not currently on nucleos(t)ide therapy will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
Group II: Cohort 2: GSK3228836 300 mg + LD/ PlaceboExperimental Treatment2 Interventions
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
Group III: Cohort 2: GSK3228836 300 mg + LD/ GSK3228836 150 mg + PlaceboExperimental Treatment2 Interventions
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
Group IV: Cohort 2: GSK3228836 300 mg + LDExperimental Treatment1 Intervention
Eligible participants not currently on nucleos(t)ide therapy will receive 300 mg GSK3228836 once weekly for 24 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11.
Group V: Cohort 1: Placebo/ GSK3228836 300 mg + Placebo LDExperimental Treatment3 Interventions
Eligible participants on stable nucleos(t)ide treatment will receive placebo once weekly for 12 weeks followed by 300 mg GSK3228836 once weekly for 12 weeks along with placebo LD to match on Day 4 and Day 11.
Group VI: Cohort 1: GSK3228836 300 mg + LD/ PlaceboExperimental Treatment3 Interventions
Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by placebo once weekly for 12 weeks.
Group VII: Cohort 1: GSK3228836 300 mg + LD/ GSK3228836 150 mg + PlaceboExperimental Treatment3 Interventions
Eligible participants on stable nucleos(t)ide treatment will receive 300 mg GSK3228836 once weekly for 12 weeks along with LD of 300 mg GSK3228836 on Day 4 and Day 11 followed by step-down in dose of 150 mg GSK3228836 once weekly for 12 weeks along with placebo to match to maintain participant blinding.
Group VIII: Cohort 1: GSK3228836 300 mg + LDExperimental Treatment2 Interventions
Eligible participants on stable nucleos(t)ide treatment will receive 300 milligrams (mg) GSK3228836 once weekly for 24 weeks along with loading dose (LD) of 300 mg GSK3228836 on Day 4 and Day 11.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nucleos(t)ide therapy
2020
Completed Phase 2
~470
Placebo
1995
Completed Phase 3
~2670
GSK3228836
2020
Completed Phase 2
~610

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,802 Previous Clinical Trials
8,377,545 Total Patients Enrolled
168 Trials studying Hepatitis B
340,322 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,604 Previous Clinical Trials
6,144,251 Total Patients Enrolled
130 Trials studying Hepatitis B
332,877 Patients Enrolled for Hepatitis B
~87 spots leftby Nov 2025
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