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Virus Therapy

Long-Term Follow-Up for GSK3228836 in Hepatitis B

Phase 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who have previously received at least one dose of GSK3228836 and 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)
Capable of giving signed informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 0, 2.5, 9, 15, 21, 27, 33
Awards & highlights

Study Summary

This trial is to see how well a previous GSK3228836 treatment worked in the long term. No new treatment will be given.

Who is the study for?
This trial is for people who have had Hepatitis B and were previously treated with GSK3228836, achieving full or partial virus control. They must be able to stop their current antiviral meds as per the study's schedule and give informed consent. Those in other HBV studies or with conditions that make participation risky can't join.Check my eligibility
What is being tested?
The study isn't testing a new treatment; instead, it's checking how long the effects of GSK3228836 last in patients who've already taken it. It looks at whether they maintain low levels of hepatitis B surface antigen (HBsAg) and DNA without further doses.See study design
What are the potential side effects?
Since no additional GSK3228836 will be given in this follow-up study, there are no direct side effects being tested. However, participants' health will be monitored for any late-occurring effects from their previous treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've had a successful treatment with GSK3228836 for hepatitis B.
Select...
I am able to understand and sign the consent form.
Select...
I have had GSK3228836 before and it partially worked for me.
Select...
I am willing to stop my current NA treatment if required by the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 0, 2.5, 9, 15, 21, 27, 33
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 0, 2.5, 9, 15, 21, 27, 33 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from NA cessation to the loss of SVR-NA controlled participants
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
Secondary outcome measures
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
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])
Absolute values for hepatitis B core related antigen (HbcrAg) (kiloUnits per milliliter [kU/mL])
+21 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%
Injection site induration
10%
Myalgia
10%
Fatigue
10%
Rash
10%
Injection site swelling
9%
Injection site discomfort
9%
COVID-19
6%
Injection site haematoma
6%
Back pain
6%
Complement factor C4 decreased
6%
Complement factor C3 decreased
6%
Nausea
6%
Dizziness
6%
Pruritus
4%
Diarrhoea
4%
Antineutrophil cytoplasmic antibody positive
4%
Urticaria
4%
Malaise
4%
Upper respiratory tract infection
4%
Pain in extremity
4%
Abdominal pain upper
4%
Platelet count decreased
4%
Arthralgia
4%
Haematuria
4%
Oropharyngeal pain
3%
Muscular weakness
3%
Influenza like illness
3%
Flank pain
3%
Erythema
3%
Neutropenia
3%
Abdominal pain
3%
Chills
3%
Decreased appetite
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%
Petechiae
1%
Rash maculo-papular
1%
Abdominal pain lower
1%
Epicondylitis
1%
Rhinorrhoea
1%
Abdominal discomfort
1%
Hyperthermia
1%
Swelling
1%
Complement factor increased
1%
Adenomyosis
1%
Lymph node pain
1%
Gastrointestinal sounds abnormal
1%
Hepatic function abnormal
1%
Nail injury
1%
Infection
1%
Eye injury
1%
Oral infection
1%
Vaccination complication
1%
Protein urine present
1%
Hypoaesthesia
1%
Lethargy
1%
Dysgeusia
1%
Nephrolithiasis
1%
Thrombocytosis
1%
Feeling abnormal
1%
Furuncle
1%
Hepatitis B
1%
Oral herpes
1%
Skin abrasion
1%
Complement factor abnormal
1%
Polydipsia
1%
Joint swelling
1%
Muscle twitching
1%
Blood bilirubin increased
1%
Constipation
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
GSK3228836 for 12+12 WK (Not on NA Therapy)
Placebo for 12 WK + GSK3228836 for 12 WK (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

2Treatment groups
Experimental Treatment
Group I: Nucleos(t)ide analogue (NA) naïve participantsExperimental Treatment1 Intervention
Participants who have not received NA therapy during the parent study. No study treatment will be administered in this study.
Group II: NA controlled participantsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GSK3228836
2020
Completed Phase 2
~590

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,366 Total Patients Enrolled
165 Trials studying Hepatitis B
339,856 Patients Enrolled for Hepatitis B
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,480 Total Patients Enrolled
129 Trials studying Hepatitis B
332,763 Patients Enrolled for Hepatitis B

Media Library

GSK3228836 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04954859 — Phase 2
Hepatitis B Research Study Groups: Nucleos(t)ide analogue (NA) naïve participants, NA controlled participants
Hepatitis B Clinical Trial 2023: GSK3228836 Highlights & Side Effects. Trial Name: NCT04954859 — Phase 2
GSK3228836 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04954859 — Phase 2
Hepatitis B Patient Testimony for trial: Trial Name: NCT04954859 — Phase 2

Frequently Asked Questions

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

Could you expound upon the potential risks of GSK3228836 for users?

"GSK3228836 was awarded a score of 2 due to available evidence which suggested that the drug is safe, but no clinical data demonstrating efficacy had been collected yet."

Answered by AI

How many participants are engaged in the current clinical trial?

"Affirmative. Clinicaltrials.gov contains information which reveals that this clinical trial, originally posted on November 25th 2021, is currently enrolling participants. Altogether 450 individuals need to be recruited from two distinct sites."

Answered by AI

Has GSK3228836 been evaluated in prior research projects?

"Currently, 3 studies are investigating GSK3228836; none of which in the final phase. London, Ontario is home to the majority of these clinical trials but other sites around 90 locations have been identified as well."

Answered by AI

Are there opportunities for new participants to join this clinical trial?

"According to clinicaltrials.gov, this research endeavour is actively seeking participants; the trial was initially listed on November 25th 2021 and its contents were recently updated a year later on November 24th 2022."

Answered by AI

Is this a pioneering research endeavor?

"The investigation of GSK3228836 officially began in 2020, when GlaxoSmithKline funded the first trial involving 20 participants. After being granted Phase 2 drug approval later that year, there are currently 3 ongoing studies for this medication spread out across 19 different nations and 18 cities."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
What state do they live in?
Ontario
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Would like to cure the recent blood test I had with Hep B.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. GSK Investigational Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)
2021. "Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04954859.
All > Autoimmune Hepatitis > Hepatitis B
~300 spots leftby Oct 2029
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