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Interferon

VIR-2218 + Peginterferon Alfa-2a for Chronic Hepatitis B

Q: How may I join the cohort of those participating in this research?

Eligibility criteria for this clinical trial demands 50 patients, aged 18 to 65 years old, who have a diagnosis of chronic <a href="https://www.withpower.com/clinical-trials/hepatitis-b">hepatitis b</a>.

Q: Has the FDA granted authorization for a single-arm, open label approach?

The safety profile of the single arm, open label trial has been rated as a 2 on our scale. This is because there are preliminary data suggesting this intervention's security but no evidence regarding its efficacy yet.

Q: Is enrollment for this experiment still open?

Clinicaltrials.gov indicates that this research project is no longer accepting participants, as the last update was made on October 20th 2023 and it was initially posted on October 26th of the same year. Fortunately, there are 272 other trials actively recruiting right now.

Q: Are participants of this experiment limited to individuals who are less than forty years old?

This trial requires that participants are aged between 18 and 65. There are 21 trials offering aid to those younger than 18, and 223 for people who surpass the age of 65.

Phase 2

Waitlist Available

Led By Marc G Ghany, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

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

Must have

Age >=18-65 years

HBsAg positive with a level <2,000 IU/mL at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months off-treatment

Awards & highlights

Study Summary

This trial will test 2 drugs to treat HBV infection in people aged 18-65. Participants receive injections and hospital visits for over 2 years.

Who is the study for?

Adults aged 18 to 65 with mild or inactive chronic hepatitis B can join this trial. They must have specific levels of HBV DNA and antigens, normal liver enzyme levels, and agree to use effective contraception. Those who are pregnant, breastfeeding, have other liver infections or diseases like cirrhosis or cancer, recent treatments for HBV, certain medical conditions or drug use that could interfere with the study cannot participate.Check my eligibility

What is being tested?

The trial is testing VIR-2218 and peginterferon alfa-2a in people with chronic hepatitis B over a period of more than two years. Participants will receive monthly injections of VIR-2218 for six months and weekly shots of peginterferon for six months at home or in the clinic. The study includes hospital stays for liver biopsies and other tests.See study design

What are the potential side effects?

Possible side effects from VIR-2218 and peginterferon alfa-2a may include flu-like symptoms such as fever, chills, muscle aches; injection site reactions; fatigue; changes in blood counts; thyroid issues; depression; vision changes due to eye exams required by the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 65 years old.

Select...

I have hepatitis B with a low viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months off-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months off-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months off-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Decline in log quantitative HBsAg level

Secondary outcome measures

Changes in innate and adaptive host immune responses to HBV during and after treatment.

Functional cure which is defined as undetectable HBsAg (<0.085 IU/ml) AND sustained suppression of HBV DNA [< LLOQ], <10 IU/ml)] for more than 6 months after discontinuation of all treatment

HBV DNA <10 IU/ml at end of treatment and 6 months off treatment. The response will be reported as HBV DNA <LLOQ target detected (TD) or target not detected (TND)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single arm, open labelExperimental Treatment1 Intervention

open label

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor

2,359 Previous Clinical Trials

4,315,445 Total Patients Enrolled

Marc G Ghany, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

13 Previous Clinical Trials

1,629 Total Patients Enrolled

Frequently Asked Questions

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

How may I join the cohort of those participating in this research?

"Eligibility criteria for this clinical trial demands 50 patients, aged 18 to 65 years old, who have a diagnosis of chronic hepatitis b."

Answered by AI

Has the FDA granted authorization for a single-arm, open label approach?

"The safety profile of the single arm, open label trial has been rated as a 2 on our scale. This is because there are preliminary data suggesting this intervention's security but no evidence regarding its efficacy yet."

Answered by AI

Is enrollment for this experiment still open?

"Clinicaltrials.gov indicates that this research project is no longer accepting participants, as the last update was made on October 20th 2023 and it was initially posted on October 26th of the same year. Fortunately, there are 272 other trials actively recruiting right now."

Answered by AI

Are participants of this experiment limited to individuals who are less than forty years old?

"This trial requires that participants are aged between 18 and 65. There are 21 trials offering aid to those younger than 18, and 223 for people who surpass the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B

2024. "VIR-2218 and Peginterferon Alfa-2a for Chronic Hepatitis B". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06092333.

All > Hepatitis B