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Subcutaneous Bepirovirsen for Hepatitis B

Phase 1

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 64

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a medication given as a shot, either from a vial or a ready-to-use device. It will also assess if the patient can administer it themselves.

Who is the study for?

Healthy adults who can consent to study requirements are eligible for this trial. They must have normal medical evaluations, including lab tests and vital signs, and not be enrolled in other studies. Exclusions include abnormal blood pressure, positive tests for HBV, HCV or HIV, recent COVID-19 symptoms or infection, use of certain medications including immunosuppressives and oligonucleotides, significant blood loss recently, drug abuse history or regular alcohol consumption.Check my eligibility

What is being tested?

The study is testing the bioavailability (how well the body absorbs) of Bepirovirsen when delivered from a vial versus a prefilled syringe with safety device in healthy participants. It will also evaluate self-administration using the prefilled syringe and monitor the safety and tolerability of Bepirovirsen.See study design

What are the potential side effects?

While specific side effects are not listed here for Bepirovirsen as it's being tested on healthy individuals primarily for absorption rates rather than treatment efficacy at this stage; generally such trials look out for any adverse reactions ranging from local site reactions to systemic effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 64

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 64

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 64 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 Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants

Maximum Observed Concentration (Cmax) of Plasma Bepirovirsen in Group 1 vs Group 2 Participants

Secondary outcome measures

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 3 Participants

Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero Extrapolated to Infinity (0-Inf) of Plasma Bepirovirsen in Group 2 vs Group 4 Participants

Maximum Observed Concentration of Plasma Bepirovirsen in Group 2 vs Group 3 Participants

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD self- administered with no training by HCP.

Group II: Group 3Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD self- administered with training by HCP.

Group III: Group 2Experimental Treatment1 Intervention

Participants will receive Bepirovirsen PFS SSD administered by HCP.

Group IV: Group 1Experimental Treatment1 Intervention

Participants will receive Bepirovirsen vial administered by Healthcare Professionals (HCP).

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,675 Total Patients Enrolled

165 Trials studying Hepatitis B

340,146 Patients Enrolled for Hepatitis B

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,780 Total Patients Enrolled

129 Trials studying Hepatitis B

333,053 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.

What level of peril do those in Group 1 face?

"Given the small number of data supporting safety and efficacy, Group 1's rate for this metric was set at a conservative score of 1."

Answered by AI

Am I eligible to partake in this medical research endeavor?

"To be eligable for this study, candidates should possess hepatitis b and have a valid age between 18 to 55. Approximately 200 volunteers are being sought out."

Answered by AI

Is eligibility for this trial restricted to individuals under 45 years of age?

"Applicants in the 18-55 age range must meet certain criteria to be eligible for this clinical trial. There are 21 studies available to minors and 222 trials ideal for people over 65 years of age."

Answered by AI

Is there an ongoing recruitment of participants for this investigation?

"The data on clinicaltrials.gov states that this trial is not presently recruiting participants. It was posted online on September 26th 2023 and subsequently updated on the 22nd of the same month, but it appears to have ceased enrollment at present. Fortunately, there are 272 other trials actively searching for patients right now."

Answered by AI

What are the designed objectives of this research?

"The primary goal of this medical trial is to compare the Area Under the Curve (AUC) from time zero extrapolated to infinity between Group 1 and Group 2 participants over a period of 64 days. Additionally, there are three secondary objectives: AUC comparison between Group 2 and Groups 3/4 participants, maximum observed concentration in Plasma Beppirovirsen for both groups being compared, as well as another AUC comparison involving Groups 2 and 4 with blood samples collected at specified intervals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants

2023. "A Study to Evaluate the Relative Bioavailability of Subcutaneous Bepirovirsen When Delivered From a Vial or Prefilled Syringe Fitted With a Safety Syringe Device in Healthy Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06058390.

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