A Phase 3 interventional study of Ribavirin and Tenofovir in Hepatitis B, Chronic, sponsored by Ottawa Hospital Research Institute. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Ottawa Hospital Research Institute · Phase 3, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 24 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
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Exclusion Criteria:
Tenofovir (TDF) 300 mg po once a day (OD)
Drug: Tenofovir
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
Drug: Ribavirin · Drug: Tenofovir
Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.
Tenofovir as per standard of care
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).
Time frame: 24 weeks
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.
Time frame: 24 weeks
Liver enzyme values
Participants individual reduction in liver enzymes at each visit.
Time frame: 24 weeks
Number of participants with treatment related adverse events as assessed by CTCAE v4.0.
Safety profile of TDF plus Ribavirin regime
Time frame: 28 weeks
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Ottawa Hospital Research Institute