What is the mechanism of action of this treatment?

Common treatments for Chronic Hepatitis B (CHB) include antiviral medications like entecavir and tenofovir, which inhibit the hepatitis B virus (HBV) DNA polymerase, thereby preventing viral replication. Pegylated interferon works by enhancing the immune response to HBV, promoting the clearance of infected cells. These mechanisms are crucial for CHB patients as they help reduce viral load, minimize liver damage, and lower the risk of liver cirrhosis and hepatocellular carcinoma. Investigational drugs like RO7565020 are being studied to further improve safety, tolerability, and efficacy, potentially offering new therapeutic options for better management of CHB.

What side effects are associated with this type of intervention?

Common treatments for Chronic Hepatitis B, such as peginterferon alfa-2a and tenofovir, have well-documented side effects. Peginterferon alfa-2a can cause adverse events like fatigue, headache, nausea, and serious adverse events in a small percentage of patients, including liver failure and lamivudine-resistant mutations. Tenofovir is generally well-tolerated but can lead to elevated alanine aminotransferase levels after discontinuation. Other antiviral therapies, such as bepirovirsen and ABI-H0731, have shown mild to moderate side effects, including local injection site reactions and general tolerability issues. Overall, these treatments are considered safe but require monitoring for potential adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Hepatitis B, focusing on safety, tolerability, pharmacokinetics, and pharmacodynamics. Entecavir, a nucleoside analog, has been extensively studied and shown to be effective in viral suppression and improving liver histology with a favorable safety profile. Pegylated interferon alfa-2a has also been approved, offering an alternative mechanism of action by boosting the immune response to the virus. These treatments have been pivotal in managing Chronic Hepatitis B, providing a foundation for newer therapies like RO7565020, which are currently under investigation.

What other types of research exist?

Promising alternatives to RO7565020 for chronic hepatitis B patients include Pegylated Interferon (PegIFN) and nucleos(t)ide analogues such as entecavir and tenofovir. PegIFN, either alone or in combination with nucleos(t)ide analogues, has shown improved rates of HBeAg and HBsAg loss. Entecavir and tenofovir are well-established treatments with proven efficacy in reducing HBV DNA levels and improving liver function. Combination therapies involving PegIFN and nucleos(t)ide analogues have demonstrated enhanced virological responses and may offer a robust treatment option for CHB patients in 2024.

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Nucleos(t)ide analogue

RO7565020 for Chronic Hepatitis B

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial tests a new drug called RO7565020 to see if it is safe and how it behaves in the body. It includes healthy people and those with chronic hepatitis B. Researchers aim to understand how the drug moves through and affects the body.

Who is the study for?

This trial is for healthy adults or those with chronic hepatitis B (CHB) who have a BMI of 18-32 kg/m^2. CHB participants must have been positive for HBsAg for at least 6 months and on NUC therapy for over a year without signs of advanced liver disease. People with cirrhosis, suspected cancer, or other significant diseases are excluded.

What is being tested?

The study tests RO7565020's safety and effects in humans compared to a placebo. It's the first time this drug is being tried in people. The trial will gradually increase doses to find safe levels and see how the body reacts over single or multiple doses in both healthy individuals and those with suppressed CHB.

What are the potential side effects?

Since this is an early-phase trial, specific side effects of RO7565020 aren't fully known yet. However, potential risks may include reactions at the injection site, flu-like symptoms, nausea, fatigue, headache, and possible liver-related issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RO7565020Experimental Treatment2 Interventions

Group II: PlaceboPlacebo Group1 Intervention

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Hepatitis B (CHB) include antiviral medications like entecavir and tenofovir, which inhibit the hepatitis B virus (HBV) DNA polymerase, thereby preventing viral replication. Pegylated interferon works by enhancing the immune response to HBV, promoting the clearance of infected cells. These mechanisms are crucial for CHB patients as they help reduce viral load, minimize liver damage, and lower the risk of liver cirrhosis and hepatocellular carcinoma. Investigational drugs like RO7565020 are being studied to further improve safety, tolerability, and efficacy, potentially offering new therapeutic options for better management of CHB.

[Clinical considerations in the design of clinical trial for innovative hepatitis B drugs].Antiviral treatment for treatment-naïve chronic hepatitis B: systematic review and network meta-analysis of randomized controlled trials.Liver safety assessment in clinical trials of new agents for chronic hepatitis B.