Clinical trial NCT03759782: Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity
Official title: Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis B, Chronic
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks
2. HBV DNA level \>20,000 IU/mL
3. ≥ 18 years of age

Exclusion Criteria:

1. Willingness and ability to sign an informed consent
2. HBV nucleos(t)ides and/or interferon exposure within 24 weeks of study medication dosing
3. 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)
4. HCV co-infected
5. Cirrhosis (defined by biopsy criteria or as \>18.4 kilopascal (kPa) by transient elastography)
6. Creatinine Clearance \<60 ml/min
7. Baseline hemoglobin \<130 g/L in males and \<120 g/L in females
8. Unwilling or unable to use contraception (unless confirmed surgical sterilization)
9. Pregnancy confirmed by blood test

Primary outcomes:
measure: The Decline of Participants Serum HBV DNA values for both study arms at each study.
timeFrame: 24 weeks
Secondary outcomes:
measure: Fibroscan score
timeFrame: 24 weeks
measure: Liver enzyme values
timeFrame: 24 weeks
measure: Number of participants with treatment related adverse events as assessed by CTCAE v4.0.
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Cumming School of Medicine, University of Calgary
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Curtis L Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References: