Ribavirin to Enhance Hepatitis B Virus Nucleotide Analog Antiviral Activity

NCT ID: NCT03759782

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2022-09-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Tenofovir

Intervention Type: DRUG

Tenofovir as per standard of care

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

Group Type: ACTIVE_COMPARATOR

Ribavirin

Intervention Type: DRUG

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

Tenofovir

Intervention Type: DRUG

Tenofovir as per standard of care

Interventions

Ribavirin

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

Intervention Type: DRUG

Tenofovir

Tenofovir as per standard of care

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Curtis L Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Cumming School of Medicine, University of Calgary

Calgary, Alberta, Canada

Site Status: RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Curtis L Cooper, MD

Role: CONTACT

ccooper@toh.ca

613.737.8924

Miriam I Muir, RN BA

Role: CONTACT

mimmuir@toh.ca

613737.8899 ext. 72723

Facility Contacts

Carla Coffin, MD

Role: primary

cacoffin@ucalgary.ca

403-592-5049

Leah Kilvert, BSCN

Role: backup

lvkilver@ucalgary.ca

403.220.8966

Curtis Cooper, MD

Role: primary

ccooper@toh.ca

6137378924

Miriam Muir, RN

Role: backup

mmuir@toh.ca

6137378899 ext. 72723

References

Keeshan A, Coffin C, Vachon A, Patel N, Fung S, Mortimer L, Crawley A, Ma M, Osiowy C, Cooper C. Ribavirin Does Not Enhance Hepatitis B Virus Nucleotide Antiviral Activity: A Pilot Study. Clin Invest Med. 2022 Dec 31;45(4):E11-15. doi: 10.25011/cim.v45i4.39274.

Reference Type: DERIVED

PMID: 36586101 (View on PubMed)

Other Identifiers

20180733

Identifier Type: -

Identifier Source: org_study_id