VIR-2218 + Peginterferon Alfa-2a for Chronic Hepatitis B
Recruiting in Palo Alto (17 mi)
Overseen byMarc G Ghany, M.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Must not be taking: Theophylline, Methadone
Disqualifiers: Pregnancy, HIV, Cirrhosis, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?Background:
Chronic hepatitis B virus (HBV) infection affects 292 million people worldwide; 887,000 die each year from cirrhosis, liver cancer, and related issues. Treatment options are limited.
Objective:
To test 2 drugs (VIR-2218 and peginterferon) in people with mild or inactive HBV infection.
Eligibility:
People aged 18 to 65 years with mild or inactive HBV infection.
Design:
Participants will be screened. They will have blood tests and an eye exam. They will have imaging scans of the liver to check the health of the liver.
Participants will be in the study for over 2 years.
VIR-2218 is an injection given under the skin of the stomach, upper arm, or thigh. Participants will come to the clinic to receive this injection once a month for 6 months.
Peginterferon is also injected under the skin. Participants will have this shot once a week for 6 months. They may either inject themselves at home or come to the clinic to get the injections.
Participants will get just the VIR-2218 for 3 months, then both shots for 3 months, then just the peginterferon for 3 months.
Participants will have two 3-day stays in the hospital. Tests will include:
Liver biopsy. A sample of tissue will be taken from their liver. After the procedure, participants will lie on their right side for 2 hours and then on their back for 4 hours.
Fine needle aspiration. A small needle will be used to collect cells from the liver.
After the last injection of peginterferon, follow-up visits will continue in the outpatient clinic every 4 to 12 weeks.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using oral theophylline, methadone, or have had any treatment for HBV in the last 24 weeks.
What data supports the effectiveness of the drug Peginterferon Alfa-2a for treating chronic hepatitis B?
Research shows that Peginterferon Alfa-2a can lead to seroconversion (a change from a negative to a positive blood test result) in up to 36% of patients with chronic hepatitis B, indicating its potential effectiveness in treating the condition.
12345What is known about the safety of Peginterferon Alfa-2a in humans?
Peginterferon Alfa-2a has been studied for safety in patients with chronic hepatitis B and hepatitis C, showing it can be used safely, though the dose may affect the safety profile. It has been evaluated in various studies, including those with different doses, and is generally considered safe for human use in these conditions.
56789How is the drug VIR-2218 + Peginterferon Alfa-2a unique for treating chronic hepatitis B?
The combination of VIR-2218 and Peginterferon Alfa-2a is unique because it combines a novel small interfering RNA (siRNA) therapy, VIR-2218, which targets the hepatitis B virus at the genetic level, with Peginterferon Alfa-2a, a long-used antiviral that boosts the immune response. This dual approach aims to enhance treatment effectiveness compared to using Peginterferon Alfa-2a alone.
13101112Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 65 years old.
You have tested negative for the hepatitis B e antigen.
Your Hepatitis B Virus DNA levels have been less than 10,000 IU/mL on two separate occasions at least 24 weeks apart, with the second measurement taken at time of screening.
+2 more
Exclusion Criteria
I do not have other liver conditions like hemochromatosis or alcoholic liver disease.
Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study
I am allergic to specific genetic therapies or interferon treatments.
+25 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive VIR-2218 injections once a month for 3 months, followed by combination treatment with peginterferon alfa-2a weekly for 3 months, and then peginterferon alfa-2a alone weekly for another 3 months
36 weeks
Monthly visits for VIR-2218, weekly visits or self-administration for peginterferon
Follow-up
Participants are monitored for safety and effectiveness after treatment
84 weeks
Visits every 4 to 12 weeks
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Single arm, open labelExperimental Treatment1 Intervention
open label
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
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Who Is Running the Clinical Trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
References
[Responses of peginterferon-alpha 2a antiviral therapy in chronic hepatitis B patients]. [2018]To study the responses of peginterferon-alpha 2a antiviral therapy in chronic hepatitis B (CHB) patients.
A simple-to-use score system for predicting HBsAg clearance to peginterferon alfa-2b in nucleoside analogs-experienced chronic hepatitis B patients. [2023]Patients with chronic hepatitis B (CHB) often fail to achieve clearance of the hepatitis B surface antigen (HBsAg) with peginterferon treatment. Our study aimed to develop a simple-to-use scoring system to predict the likelihood of HBsAg clearance following treatment with peginterferon alfa-2b(PEG-IFN-α2b) in patients with CHB.
Sustained efficacy of adefovir add-on therapy in chronic hepatitis B patient with a poor virological response to peginterferon alfa. [2018]Currently, there is no consensus on the recommendation of peginterferon alfa (pegIFNα) to chronic hepatitis B (CHB) patients with poor viral response (EVR). This study aimed to assess the sustained curative efficacy of adefovir (ADV) add-on therapy in optimizing pegIFNα monotherapy.
A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. [2022]Treatment with pegylated interferon (peg-IFN) alfa-2a (40KD) results in hepatitis B "e" antigen (HBeAg) seroconversion 6 months after treatment in up to 36% of HBeAg-positive chronic hepatitis B patients. This study explored the efficacy of a novel combination of peg-IFN alfa-2a and entecavir (ETV), a potent nucleoside analogue.
[HBeAg seroconversion achieved by sequential peginterferon alfa-2a therapy in chronic hepatitis B patients with unsatisfactory end point following entecavir treatment]. [2018]To investigate the efficacy and safety of peginterferon alfa-2a (Peg-IFNa-2a) therapy for treating chronic hepatitis B (CHB) in patients who failed to achieve a satisfactory end point with entecavir (ETV) treatment.
Efficacy and safety of peginterferon alpha-2a (40KD) in HBeAg-positive chronic hepatitis B patients. [2018]The study was designed to evaluate the efficacy and safety of peginterferon alpha-2a in HBeAg-positive chronic hepatitis B patients, nonresponders or relapsers after previous lamivudine or standard interferon therapy.
Safety profile of standard- vs. high-dose peginterferon alfa-2a plus standard-dose ribavirin in HCV genotype 1/4 patients: pooled analysis from 5 randomized studies. [2018]This analysis examines the safety profile of standard- versus high-dose peginterferon alfa-2a.
Efficacy and safety of peginterferon alpha monotherapy in Chinese inactive chronic hepatitis B virus carriers. [2021]The effectiveness and safety of peginterferon alpha (peg-IFN-α) monotherapy in inactive hepatitis B virus (HBV) carriers (IHCs) have not been fully evaluated.
[Pegylated interferon alpha 2a in treating chronic hepatitis B patients]. [2018]To evaluate the efficacy and safety of pegylated interferon alpha 2a (PEG-IFN alpha-2a) in treating patients with chronic hepatitis B.
Predictors of response to pegylated interferon treatment in HBeAg-negative patients with chronic hepatitis B. [2018]Although pegylated interferons (pegIFNs) alpha-2a and alpha-2b have been used in chronic hepatitis B (CHB) treatment for many years, there are few studies concerning predictors of sustained virologic response (SVR) to pegIFN therapy. In this study, we aimed to investigate the predictors of response to pegIFN treatment in cases with HBeAg-negative CHB infection.
Polymorphisms near IL28B and serologic response to peginterferon in HBeAg-positive patients with chronic hepatitis B. [2023]A limited number of patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B respond to treatment with peginterferon alfa (PEG-IFN). We investigated whether IL28B genotypes are associated with response.
Efficacy of peginterferon α-2a and predictors of response in HBeAg-negative, genotype D-naive patients. [2021]Peginterferon (PEG-IFN) α-2a has been shown to induce a sustained virologic response (SVR) in 20-30% of "hepatitis B e antigen (HBeAg)"-negative patients.