Status:
UNKNOWN
Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ab...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03759782
Start Date
January 10 2019
End Date
September 30 2022
Last Update
September 14 2021
Active Locations (2)
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1
Cumming School of Medicine, University of Calgary
Calgary, Alberta, Canada, T2N4Z6
2
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6