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Anti-viral

Tenofovir for Chronic Hepatitis B

Phase 3
Waitlist Available
Led By Curtis L Cooper, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HBV Hepatitis B surface antigen (HBsAg) positive for a minimum of 24 weeks
HBV DNA level >20,000 IU/mL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 weeks
Awards & highlights

Study Summary

This trial will explore whether adding Ribavirin to standard HBV treatment (using nucleoside analogues) will be more effective in clearing the virus.

Eligible Conditions
  • Chronic Hepatitis B

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The Decline of Participants Serum HBV DNA values for both study arms at each study.
Secondary outcome measures
Fibroscan score
Liver enzyme values
Number of participants with treatment related adverse events as assessed by CTCAE v4.0.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1Experimental Treatment1 Intervention
Tenofovir (TDF) 300 mg po once a day (OD)
Group II: Group 2Active Control2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenofovir
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,667 Total Patients Enrolled
Curtis L Cooper, MDPrincipal InvestigatorOttawa Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity
2019. "Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03759782.
All > Autoimmune Hepatitis > Hepatitis B
~4 spots leftby Apr 2025
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