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GSK3228836 for Hepatitis B

Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight >50 Kilogram (kg) and body mass index (BMI) within the range 19 to 40 Kilogram per square meters (kg/m2) (inclusive)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 168 hours post-dose
Awards & highlights

Study Summary

This study is evaluating whether a drug can be safely given to people with liver disease.

Eligible Conditions
  • Hepatitis B

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
People who weigh more than 50 kg and have a BMI within the range of 19 to 40 kg/m2 are considered to be overweight or obese.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 168 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC) from time zero (pre-dose) extrapolated to infinite time [AUC(0-infinity)]
Maximum observed concentration (Cmax)
Secondary outcome measures
AUC from time zero (pre-dose) to 168 hours [AUC(0-168)]
AUC from time zero (pre-dose) to 24 hours [AUC(0-24)]
Apparent clearance (CL/F)
+4 more

Side effects data

From 2022 Phase 2 trial • 457 Patients • NCT04449029
49%
Injection site erythema
33%
Injection site pruritus
29%
Injection site pain
24%
Alanine aminotransferase increased
21%
Pyrexia
20%
Headache
19%
Fatigue
19%
Injection site bruising
19%
Injection site discolouration
14%
Myalgia
14%
Injection site swelling
11%
Injection site haematoma
11%
Platelet count decreased
11%
Aspartate aminotransferase increased
10%
Complement factor C3 decreased
10%
Nausea
9%
Complement factor increased
9%
Injection site induration
7%
Thrombocytopenia
7%
Chills
7%
Complement factor C4 decreased
7%
Pruritus
6%
Back pain
6%
Neutropenia
6%
Nasopharyngitis
6%
Pain in extremity
6%
Abdominal pain
6%
Injection site discomfort
4%
Leukopenia
4%
C-reactive protein increased
4%
Diarrhoea
4%
Toothache
4%
Malaise
4%
Abdominal pain upper
4%
Vomiting
4%
Asthenia
4%
COVID-19
4%
Upper respiratory tract infection
4%
Urinary tract infection
4%
Dizziness
4%
Haematuria
4%
Oropharyngeal pain
3%
Influenza like illness
3%
Vulvovaginal candidiasis
3%
Anaemia
3%
Iron deficiency anaemia
3%
Proteinuria
3%
Vertigo
3%
Abdominal pain lower
3%
Constipation
3%
Urticaria
3%
Injection site warmth
3%
Cystitis
3%
Influenza
3%
Pharyngitis
3%
Contusion
3%
Blood alkaline phosphatase increased
3%
Blood creatinine increased
3%
Body temperature increased
3%
Alopecia
3%
Erythema
3%
Hypertension
3%
Ear pain
1%
Meniere's disease
1%
Chest pain
1%
Costochondritis
1%
Dry skin
1%
Lymphopenia
1%
Faeces discoloured
1%
Seasonal allergy
1%
Glomerular filtration rate decreased
1%
Creatinine urine increased
1%
Gamma-glutamyltransferase increased
1%
Dyspepsia
1%
Gastrooesophageal reflux disease
1%
White blood cell count decreased
1%
Haematoma
1%
Hypotension
1%
Blood bilirubin increased
1%
Irritability
1%
Large intestine polyp
1%
Polycythaemia
1%
Abdominal distension
1%
Pain
1%
Vaccination site pain
1%
Hepatic function abnormal
1%
Bronchitis
1%
Vaginitis gardnerella
1%
Blood potassium increased
1%
Hyperglycaemia
1%
Hypoglycaemia
1%
Lymphadenopathy
1%
Systemic inflammatory response syndrome
1%
Hepatitis B
1%
Bile duct cancer
1%
Dysuria
1%
Eosinophilia
1%
Monocytosis
1%
Tachycardia
1%
Vertigo positional
1%
Hypothyroidism
1%
Menstruation irregular
1%
Noninfective conjunctivitis
1%
Vulvovaginal inflammation
1%
Abdominal discomfort
1%
Diverticulum intestinal
1%
Upper respiratory tract inflammation
1%
Peripheral swelling
1%
Haemorrhoids
1%
Liver function test abnormal
1%
Chest discomfort
1%
Energy increased
1%
Mean cell volume decreased
1%
Injection site anaesthesia
1%
Injection site haemorrhage
1%
Non-cardiac chest pain
1%
Hepatic steatosis
1%
Food allergy
1%
Immunodeficiency
1%
Bacterial infection
1%
Diarrhoea infectious
1%
Fungal infection
1%
Protein urine present
1%
Herpes simplex
1%
Otitis media acute
1%
Sinusitis
1%
Ligament sprain
1%
Urine albumin/creatinine ratio
1%
Skin laceration
1%
Albumin urine present
1%
Antineutrophil cytoplasmic antibody positive
1%
Total complement activity decreased
1%
Blood pressure increased
1%
Transaminases increased
1%
Creatinine renal clearance decreased
1%
Hypocalcaemia
1%
Hypokalaemia
1%
Arthralgia
1%
Musculoskeletal pain
1%
Musculoskeletal stiffness
1%
Rheumatoid arthritis
1%
Cervix carcinoma
1%
Uterine leiomyoma
1%
Hypoaesthesia
1%
Somnolence
1%
Insomnia
1%
Ketonuria
1%
Leukocyturia
1%
Urine abnormality
1%
Breast pain
1%
Cervix haemorrhage uterine
1%
Pelvic pain
1%
Cough
1%
Oropharyngeal discomfort
1%
Asteatosis
1%
Dermal cyst
1%
Hyperhidrosis
1%
Purpura
1%
Rash
1%
Rash maculo-papular
1%
Hot flush
1%
Varicose vein
1%
Vascular pain
1%
Vasculitis
1%
Splenomegaly
1%
Vaginal infection
1%
Cervical polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
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 12 WK + Placebo for 12 WK (on NA Therapy)
Placebo for 12 WK + GSK3228836 for 12 WK (on NA Therapy)
GSK3228836 for 24 WK (Not on NA Therapy)
GSK3228836 for 12+12 WK (Not on NA Therapy)
GSK3228836 for 24 Weeks (WK) (on NA Therapy)
GSK3228836 for 12+12 WK (on NA Therapy)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants with Moderate (CP-B) hepatic impairmentExperimental Treatment1 Intervention
Group II: Participants with Mild (CP-A) hepatic impairmentExperimental Treatment1 Intervention
Group III: Healthy participantsExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3228836
2020
Completed Phase 2
~590

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,743 Previous Clinical Trials
8,066,487 Total Patients Enrolled
165 Trials studying Hepatitis B
340,322 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,594 Previous Clinical Trials
6,143,479 Total Patients Enrolled
129 Trials studying Hepatitis B
333,229 Patients Enrolled for Hepatitis B

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
Florida
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Average response time
  • < 2 Days
~7 spots leftby Mar 2025