Recruiting
Phase 3

Ribavirin

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03759782

Conditions

Hepatitis B, Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ribavirin

Tenofovir

Study Details

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.

Conditions

Hepatitis B, Chronic

Study ID

NCT03759782

Start date

Jan 10, 2019

Status verified date

Sep, 2021

Completion date

Sep 30, 2022

Anticipated

Primary completion date

Jan 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1

Tenofovir (TDF) 300 mg po once a day (OD)

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

Interventions

Ribavirin

Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.

Tenofovir

Tenofovir as per standard of care

Primary outcome measure

  • The Decline of Participants Serum HBV DNA values for both study arms at each study. [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Curtis L Cooper, MD

613.737.8924ccooper@toh.ca

Miriam I Muir, RN BA

613737.8899mimmuir@toh.ca

Locations

Cumming School of Medicine, University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N4Z6

Contacts

Carla Coffin, MD

403-592-5049cacoffin@ucalgary.ca

Leah Kilvert, BSCN

403.220.8966lvkilver@ucalgary.ca

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Curtis Cooper, MD

6137378924ccooper@toh.ca

Miriam Muir, RN

6137378899mmuir@toh.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Sep 14, 2021

Last verified

Sep, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2021-09-14.