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

• Status: Completed
• Trial end date: 2021-07-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan (Taiwan) Ltd
• Treatments: Tenofovir

Criteria

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.