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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 36, and 48

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

Injection site discomfort

COVID-19

Injection site haematoma

Complement factor C3 decreased

Complement factor C4 decreased

Back pain

Nausea

Dizziness

Pruritus

Diarrhoea

Antineutrophil cytoplasmic antibody positive

Malaise

Upper respiratory tract infection

Urticaria

Pain in extremity

Abdominal pain upper

Platelet count decreased

Arthralgia

Haematuria

Oropharyngeal pain

Neutropenia

Abdominal pain

Chills

Influenza like illness

Decreased appetite

Flank pain

Muscular weakness

Erythema

Pharyngitis

Creatinine renal clearance decreased

Injection site nodule

Pain

Iron deficiency anaemia

Thrombocytopenia

Abdominal distension

Non-cardiac chest pain

Herpes simplex

Influenza

Nasopharyngitis

C-reactive protein increased

Insomnia

Cough

Abdominal pain lower

Constipation

Muscle twitching

Nail injury

Skin abrasion

Lymph node pain

Thrombocytosis

Abdominal discomfort

Gastrointestinal sounds abnormal

Feeling abnormal

Hyperthermia

Vaccination complication

Swelling

Hepatic function abnormal

Blood bilirubin increased

Furuncle

Hepatitis B

Infection

Oral herpes

Oral infection

Complement factor abnormal

Complement factor increased

Protein urine present

Epicondylitis

Eye injury

Polydipsia

Joint swelling

Dysgeusia

Hypoaesthesia

Lethargy

Nephrolithiasis

Adenomyosis

Rhinorrhoea

Petechiae

Rash maculo-papular

Rash pruritic

COVID-19 pneumonia

Coagulopathy

Gastrooesophageal reflux disease

Cellulitis

Neoplasm skin

Spinal column injury

Increased tendency to bruise

Atrial fibrillation

Palpitations

Supraventricular extrasystoles

Tachycardia

Eye pain

Periorbital swelling

Catarrh

Aphthous ulcer

Acne

Gingival bleeding

Haemorrhoidal haemorrhage

Asthenia

Rash macular

Injection site anaesthesia

Injection site warmth

Gallbladder polyp

Hepatitis acute

Hypertransaminasaemia

Food allergy

Seasonal allergy

Neutrophil count decreased

Herpes zoster

Parotitis

Animal bite

Contusion

Sunburn

Activated partial thromboplastin time prolonged

Blood alkaline phosphatase increased

Muscle spasms

Musculoskeletal pain

Musculoskeletal stiffness

Osteoarthritis

Leiomyoma

Dysuria

Dysmenorrhoea

Epistaxis

Dermatitis

Dermatitis allergic

Nail bed bleeding

Umbilical erythema

Hypertension

Ear pain

Vaginal infection

100%

80%

60%

40%

20%

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

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