Status:
COMPLETED
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
Lead Sponsor:
Mylan (Taiwan) Ltd
Conditions:
Chronic Hepatitis B Infection
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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 treate...
Eligibility Criteria
Inclusion
- Ricovir® Group
- 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
- 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.
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05355467
Start Date
August 21 2019
End Date
July 13 2021
Last Update
May 2 2022
Active Locations (1)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, 40705