Clinical trial NCT05355467: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B Infection
Lead sponsor: Mylan (Taiwan) Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Assessment of the rates of virological recurrence of HBV
timeFrame: Week 24
Secondary outcomes:
measure: Comparison of the HBV DNA levels between Ricovir® group and historical control group
timeFrame: Week 24
measure: Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.
timeFrame: Week 24
measure: Monitoring of Safety profile for subjects in Ricovir® group
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Mylan Pharmaceuticals Private Limited
name: Sanjay Hadigal, Dr.
role: STUDY_DIRECTOR
References: