Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

  • STATUS
    Recruiting
  • days left to enroll
    2
  • participants needed
    24
  • sponsor
    Ottawa Hospital Research Institute
Updated on 23 September 2021
cancer
tenofovir
ribavirin
antiviral therapy
liver failure
nucleoside analog
hepatitis b antigen
antiviral drugs
hepatitis b e antigen
hepatitis b surface
hepatitis d

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.

Details
Condition chronic hepatitis b
Treatment Ribavirin, tenofovir
Clinical Study IdentifierNCT03759782
SponsorOttawa Hospital Research Institute
Last Modified on23 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks
HBV DNA level >20,000 IU/mL
18 years of age

Exclusion Criteria

Willingness and ability to sign an informed consent
HBV nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing
HIV and other immune compromising condition (e.g. cancer with the exception of non-invasive cutaneous malignancy, autoimmune condition) or therapy (i.e. systemic steroids, chemotherapy)
HCV co-infected
Cirrhosis (defined by biopsy criteria or as >18.4 kilopascal (kPa) by transient elastography)
Creatinine Clearance <60 ml/min
Baseline hemoglobin <130 g/L in males and <120 g/L in females
Unwilling or unable to use contraception (unless confirmed surgical sterilization)
Pregnancy confirmed by blood test
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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