drugset / Trial / NCT03759782

Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

NCT03759782

Phase 3 Unknown 24 enrolled Ottawa Hospital Research Institute
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-01-10
Primary completion
2022-01-31
Completion
2022-09-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ribavirin Small molecule 400 mg
Comparator Ribavirin Small molecule 600 mg
Background Tenofovir Small molecule 300 mg Oral