Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis B Infection
• Intervention / Treatment: Drug: Tenofovir disoproxil fumarate; Other: Historical Data

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Ricovir® Group

Inclusion Criteria:

• Male or female aged more than 20 years old;
• CHB patients who have been treated with Viread® for more than 1 year;
• Serum HBV DNA level is undetectable (not detected or <20 IU/mL) at screening;
• Informed consent must be obtained before the commencement of any screening procedures or study drugs

Exclusion Criteria:

• Patients with active HCC or other types of malignancy;
• Patients with impaired renal function (defined as eGFR ≦ 30 mL/min/1.73m2);
• Patients with hepatitis A (HAV), hepatitis C (HCV), hepatitis D (HDV) or human immunodeficiency virus (HIV) coinfection;
• Patients with alcohol dependence or addiction;
• Patients with autoimmune hepatitis;
• Patients with primary biliary cholangitis (PBC);
• Pregnancy, planning on getting pregnant, or breast-feeding;
• History of allergy, hypersensitivity, intolerance, or experiencing severe adverse reactions to tenofovir or any ingredient of the study drug;
• Not suitable for participating in this trial at the investigator's discretion.

Historical Control Group

Eligible individuals will be obtained from the TCVGH historical database based on matching (1:1) in terms of age (±5 years) and gender. To be eligible for the study, subjects must meet all of the following criteria:

• Male or female aged more than 20 years old;
• CHB patients who had been treated with Viread® for more than 1 year;
• Patients who had discontinued Viread® therapy for at least 24 weeks during the period from January 2014 to December 2021 and had undetectable HBV DNA (not detected or <20 IU/mL) in serum at the time of discontinuation;
• Patients who have the data of HBV DNA level 24 weeks after the time of discontinuation, with a time window of +4 weeks is allowed;
• The informed consent requirement will be waived based on the approval of IRB.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ricovir® group	Drug: Tenofovir disoproxil fumarate; Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.
Other: Historical Control Group	Other: Historical Data; Historical Data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the rates of virological recurrence of HBV	To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the HBV DNA levels between Ricovir® group and historical control group	To compare the HBV DNA levels at Week 24 between Ricovir® group and historical control group.	Week 24
Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.	To compare the rates of virological recurrence of HBV at Week 24 between Ricovir® group and historical control group.	Week 24
Monitoring of Safety profile for subjects in Ricovir® group	For subjects in Ricovir® group, physical examination, vital signs, HBV DNA level, and concomitant medications will be evaluated at Week 4, 12 and 24 after treatment. Hematology and clinical biochemistry will be performed every 12 weeks. Adverse events (AEs) will be monitored continuously during the study.	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Mylan (Taiwan) Ltd
• Investigators: Study Director: Sanjay Hadigal, Dr., Mylan Pharmaceuticals Private Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): July 13, 2021

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 29, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Hepatitis, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir
• Other Study ID Numbers: Mylan-Ricovir-TW-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No