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Trial record 3 of 10 for:    ribavirin hbv
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Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

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ClinicalTrials.gov Identifier: NCT03759782
Recruitment Status : Recruiting
First Posted : November 30, 2018
Last Update Posted : September 14, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Ribavirin Drug: Tenofovir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial
Actual Study Start Date : January 10, 2019
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
Tenofovir (TDF) 300 mg po once a day (OD)
 Drug: Tenofovir
Tenofovir as per standard of care
Active Comparator: Group 2
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
Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.

Drug: Tenofovir
Tenofovir as per standard of care


Outcome Measures
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Primary Outcome Measures :
  1. The Decline of Participants Serum HBV DNA values for both study arms at each study. [ Time Frame: 24 weeks ]
    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).


Secondary Outcome Measures :
  1. Fibroscan score [ Time Frame: 24 weeks ]
    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.

  2. Liver enzyme values [ Time Frame: 24 weeks ]
    Participants individual reduction in liver enzymes at each visit.

  3. Number of participants with treatment related adverse events as assessed by CTCAE v4.0. [ Time Frame: 28 weeks ]
    Safety profile of TDF plus Ribavirin regime


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759782


Contacts
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Contact: Curtis L Cooper, MD 613.737.8924 ccooper@toh.ca
Contact: Miriam I Muir, RN BA 613737.8899 ext 72723 mimmuir@toh.ca

Locations
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Canada, Alberta
Cumming School of Medicine, University of Calgary Recruiting
Calgary, Alberta, Canada, T2N4Z6
Contact: Carla Coffin, MD    403-592-5049    cacoffin@ucalgary.ca   
Contact: Leah Kilvert, BSCN    403.220.8966    lvkilver@ucalgary.ca   
Sub-Investigator: Carla Coffin, MD         
Canada, Ontario
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Curtis Cooper, MD    6137378924    ccooper@toh.ca   
Contact: Miriam Muir, RN    6137378899 ext 72723    mmuir@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Curtis L Cooper, MD Ottawa Hospital Research Institute
More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03759782    
Other Study ID Numbers: 20180733
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
 Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Tenofovir
Ribavirin
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antimetabolites