NCT03759782

Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatitis B virus (HBV) leads to life-threatening disease like liver failure and liver cancer. For most, a cure is unattainable as current HBV antiviral therapy (using nucleoside analogues) are not able to clear the virus from their liver. While HBV treatments are typically administered alone (monotherapy), this study will explore the use of Ribavirin in combination with standard therapy to enhance current treatment regimens. Ribavirin is commonly used to treat Hepatitis C Virus (HCV) but there is evidence that Ribavirin also induces immune effects that are beneficial in HBV treatment. The aim of this study is to determine whether combination of Ribavirin and a nucleoside analog is more effective compared to nucleoside analog treatment alone. Enrolled patients will be followed for treatment response according to standard clinical and virological tests, as well as immune response to HBV. Our ultimate goal is to find a more effective treatment and improve health outcomes for persons living with HBV.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Ribavirin	Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.
DRUG	Tenofovir	Tenofovir as per standard of care

Timeline

• Start date: 2019-01-10
• Primary completion: 2022-01-31
• Completion: 2022-09-30
• First posted: 2018-11-30
• Last updated: 2021-09-14

Locations

2 sites across 1 country: Canada