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

NCT ID: NCT05355467

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-21
• Study Completion Date: 2021-07-13

Brief 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.

Conditions

Chronic Hepatitis B Infection

Study Design

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

Study Groups

Ricovir® group

Group Type: EXPERIMENTAL

Tenofovir disoproxil fumarate

Intervention Type: DRUG

Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.

Historical Control Group

Group Type: OTHER

Historical Data

Intervention Type: OTHER

Historical Data

Interventions

Tenofovir disoproxil fumarate

Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.

Intervention Type: DRUG

Historical Data

Historical Data

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mylan (Taiwan) Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Hadigal, Dr.

Role: STUDY_DIRECTOR

Mylan Pharmaceuticals Private Limited

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

Mylan-Ricovir-TW-01

Identifier Type: -

Identifier Source: org_study_id