Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

Hepatitis B, Chronic Clinical Trial

Official title:

Use of Immune Modulatory Properties of Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity: Proposal for Pilot Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759782
• Other study ID #: 20180733
• Status: Recruiting
• Phase: Phase 3
• Start date: January 10, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2021
• Source: Ottawa Hospital Research Institute
• Contact: Curtis L Cooper, MD
• Phone: 613.737.8924
• Email: ccooper[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Ribavirin
Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.
• Tenofovir
Tenofovir as per standard of care

Locations

Country	Name	City	State
Canada	Cumming School of Medicine, University of Calgary	Calgary	Alberta
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Liver enzyme values	Participants individual reduction in liver enzymes at each visit.	24 weeks
Secondary	Number of participants with treatment related adverse events as assessed by CTCAE v4.0.	Safety profile of TDF plus Ribavirin regime	28 weeks