RO7565020 for Chronic Hepatitis B

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Hoffmann-La Roche

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications. However, if you are a healthy volunteer, you must not have used any treatment within 2 weeks or 5 half-lives before the first dose. If you have chronic hepatitis B, you must continue your NUC monotherapy.

What data supports the idea that RO7565020 for Chronic Hepatitis B is an effective treatment?

The available research shows that oral nucleos(t)ide analogues, which include treatments like RO7565020, are recommended as a first choice for chronic hepatitis B because they are effective at reducing the virus in the body and are considered safe. This suggests that RO7565020 could be effective in managing chronic hepatitis B by keeping the virus under control. ^{1 2 3 4 5}

What safety data is available for RO7565020 treatment in chronic hepatitis B?

The safety profile of nucleos(t)ide analogues, which include treatments like RO7565020, is generally well-tolerated and achieves high rates of viral suppression. Long-term use is common, and while most treatments are safe, some, like adefovir dipivoxil, may cause adverse effects such as nephrotoxicity. Entecavir and tenofovir disoproxil fumarate are preferred first-line agents due to their favorable safety profiles. ^{1 6 7 8 9}

Is the drug RO7565020 a promising treatment for Chronic Hepatitis B?

RO7565020, a type of drug known as a nucleos(t)ide analogue, is promising for treating Chronic Hepatitis B because similar drugs have been effective in managing the disease and reducing virus replication. ^{1 8 10 11 12}

Eligibility Criteria

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.

Inclusion Criteria

Healthy volunteers: Body mass index (BMI) between 18 and 32 kg/m^2

CHB participants: CHB infection (HBsAg-positive for >/= 6 months), On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months, Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis, BMI between 18 and 32 kg/m^2

Exclusion Criteria

I am healthy with no significant diseases or treatments that could affect the study.

I have liver issues not solely due to hepatitis B, or I've had cancer or immune treatments recently.

Treatment Details

Interventions

• NUC treatment (Nucleos(t)ide analogue)
• Placebo (Other)
• RO7565020 (Other)

Trial Overview 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.

Participant Groups

Group I: RO7565020 Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 1 Intervention

NUC treatment is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Nucleos(t)ide analogue for:

• Chronic hepatitis B
• HIV infection
• Herpes simplex virus infection

🇺🇸 Approved in United States as Nucleos(t)ide analogue for:

• Chronic hepatitis B
• HIV infection
• Herpes simplex virus infection

🇨🇦 Approved in Canada as Nucleos(t)ide analogue for:

• Chronic hepatitis B
• HIV infection
• Herpes simplex virus infection

🇯🇵 Approved in Japan as Nucleos(t)ide analogue for:

• Chronic hepatitis B
• HIV infection
• Herpes simplex virus infection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Quest Clinical Research San Francisco, CA

Inland Empire Liver Foundation Rialto, CA

Who Is Running the Clinical Trial?

Hoffmann-La Roche Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Persistence profile to nucleos(t)ide analogue treatment for patients with chronic hepatitis B. [2022] There are currently five approved nucleos(t)ide analogues (NUCs) for the management of chronic hepatitis B (CHB): lamivudine, adefovir dipivoxil, telbivudine, entecavir, and tenofovir disoproxil fumarate.

2. England pubmed.ncbi.nlm.nih.gov

Severe hepatitis B flares with hepatic decompensation after withdrawal of nucleos(t)ide analogues: A population-based cohort study. [2023] Finite nucleos(t)ide analogue (NUC) therapy has been proposed as an alternative treatment strategy for chronic hepatitis B (CHB).

3. England pubmed.ncbi.nlm.nih.gov

Safety of current antiviral drugs for chronic hepatitis B. [2022] Oral nucleos(t)ide analogues (NUCs) are recommended as first-line therapy for chronic hepatitis B (CHB) due to higher HBV-DNA suppression rates and safety profile. Long-term treatment with NUCs is often necessary to achieve durable viral suppression.

4. Turkey pubmed.ncbi.nlm.nih.gov

Outcomes of Cessation of Antiviral Therapy in Chronic Hepatitis B: A Retrospective Cohort Study. [2022] Data on the efficacy and duration of nucleos(t)ide analogue (NUC) therapies to prevent the development of cirrhosis and hepatocellular carcinoma in chronic hepatitis B (CHB) patients are scarce and heterogeneous. This study aimed to summarize the clinical and laboratory results of the patients with CHB infection who discontinued oral antiviral therapy.

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Antiviral Treatment on Hepatitis B Virus Integration and Hepatocyte Clonal Expansion. [2023] This study investigated the effect of nucleos(t)ide analogue (NUC) treatment on hepatitis B virus (HBV) DNA integration and hepatocyte clonal expansion, both of which are implicated in hepatocellular carcinoma (HCC) in chronic hepatitis B.

6. England pubmed.ncbi.nlm.nih.gov

Review article: long-term safety of oral anti-viral treatment for chronic hepatitis B. [2019] Safety profile of nucleos(t)ide analogues is an important issue in view of its widespread use for decades in patients with chronic hepatitis B (CHB).

7. England pubmed.ncbi.nlm.nih.gov

Review article: long-term safety of nucleoside and nucleotide analogues in HBV-monoinfected patients. [2018] Nucleos(t)ide analogues (NUCs) for chronic hepatitis B treatment achieve high rates of viral suppression and are generally well tolerated. Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are the currently preferred first-line agents. The safety of these agents in clinical practice is particularly relevant since long-term treatment is usually required.

8. Turkey pubmed.ncbi.nlm.nih.gov

Discontinuation of Nucleos(t)ide Analog treatment in HBeAg-Negative Non-Cirrhotic Chronic Hepatitis B Patients: Real-Life Data of 20 Years. [2023] Discontinuation of nucleos(t)ide analog is controversial in HBeAg-negative chronic hepatitis B patients not achieved HBsAg loss. We aimed to evaluate re-treatment rates and risk factors in non-cirrhotic HbeAg-negative chronic hepatitis B patients for whom nucleosi(t)ides analogs were discontinued.

9. England pubmed.ncbi.nlm.nih.gov

Drug safety evaluation of adefovir in HBV infection. [2013] Several nucleos(t)ide analogs (NUC) are available for the management of patients with chronic hepatitis B (CHB). In most patients, NUC need to be administered on a long-term basis, thus increasing the risk of adverse effects. Adefovir dipivoxil (ADV), the first nucloeotide analog developed to treat CHB, may indeed cause nephrotoxicity.

10. England pubmed.ncbi.nlm.nih.gov

Meta-analysis: the impact of oral anti-viral agents on the incidence of hepatocellular carcinoma in chronic hepatitis B. [2022] Five oral nucleos(t)ide analogues are available to treat chronic hepatitis B (CHB). With the availability of newer agents, their efficacy on incidence of hepatocellular carcinoma (HCC) is not well described.

11. Australia pubmed.ncbi.nlm.nih.gov

Higher adherence with 3-year entecavir treatment than lamivudine or telbivudine in treatment-naïve Taiwanese patients with chronic hepatitis B. [2014] Oral nucleos(t)ide analogs (NAs) are effective in suppressing hepatitis B virus (HBV) replication in treatment naïve chronic hepatitis B (CHB) patients. However, little is known about the treatment modification and adherence on such patients with prolonged NA treatment.

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

Efficacy and safety of long-term therapy with nucleos(t)ide analogues in chronic hepatitis B. [2019] To assess the efficacy and safety of long-term treatment with nucleos(t)ide analogues in patients with chronic hepatitis B.