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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Tenofovir (TDF) 300 mg po once a day (OD) |
|
| Group 2 | Active Comparator | Tenofovir 300 mg po OD + Ribavirin 400 mg twice a day (BID) if <70kg / 600 mg every (q) in the morning (AM) and 400 mg q in the evening (PM) if ≥70kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ribavirin | Drug | Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Decline of Participants Serum HBV DNA values for both study arms at each study. | The absolute decline in HBV DNA and quantitative HBsAg titre will be compared with baseline level at each study visit overall and between study arms (with or without RBV). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fibroscan score | Individual fibroscan scores pre and post treatment for each group, using fibrosis scores calculated in kilopascal F0 representing no fibrosis and F4 value indicating cirrhosis. | 24 weeks |
| Liver enzyme values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Curtis L Cooper, MD | Contact | 613.737.8924 | ccooper@toh.ca | |
| Miriam I Muir, RN BA | Contact | 613737.8899 | 72723 | mimmuir@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Curtis L Cooper, MD | Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumming School of Medicine, University of Calgary | Recruiting | Calgary | Alberta | T2N4Z6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36586101 | Derived | Keeshan A, Coffin C, Vachon A, Patel N, Fung S, Mortimer L, Crawley A, Ma M, Osiowy C, Cooper C. Ribavirin Does Not Enhance Hepatitis B Virus Nucleotide Antiviral Activity: A Pilot Study. Clin Invest Med. 2022 Dec 31;45(4):E11-15. doi: 10.25011/cim.v45i4.39274. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 26, 2022 | |
| Reset | Jan 26, 2023 | |
| Release | Feb 10, 2023 | |
| Reset | Nov 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 26, 2022 | Jan 26, 2023 | |||
| Feb 10, 2023 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
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Open-label
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| Tenofovir | Drug | Tenofovir as per standard of care |
|
Participants individual reduction in liver enzymes at each visit.
| 24 weeks |
| Number of participants with treatment related adverse events as assessed by CTCAE v4.0. | Safety profile of TDF plus Ribavirin regime | 28 weeks |
| Ottawa Hospital Research Institute | Recruiting | Ottawa | Ontario | K1H8L6 | Canada |
|
| Nov 21, 2023 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |