search
Back to results

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

Primary Purpose

Chronic Hepatitis B Infection

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Tenofovir disoproxil fumarate
Historical Data
Sponsored by
Mylan (Taiwan) Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B Infection

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taichung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ricovir® group

Historical Control Group

Arm Description

Outcomes

Primary Outcome Measures

Assessment of the rates of virological recurrence of HBV
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 25, 2022
Last Updated
April 29, 2022
Sponsor
Mylan (Taiwan) Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT05355467
Brief 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
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
July 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan (Taiwan) Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ricovir® group
Arm Type
Experimental
Arm Title
Historical Control Group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil fumarate
Intervention Description
Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.
Intervention Type
Other
Intervention Name(s)
Historical Data
Intervention Description
Historical Data
Primary Outcome Measure Information:
Title
Assessment of the rates of virological recurrence of HBV
Description
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Comparison of the HBV DNA levels between Ricovir® group and historical control group
Description
To compare the HBV DNA levels at Week 24 between Ricovir® group and historical control group.
Time Frame
Week 24
Title
Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.
Description
To compare the rates of virological recurrence of HBV at Week 24 between Ricovir® group and historical control group.
Time Frame
Week 24
Title
Monitoring of Safety profile for subjects in Ricovir® group
Description
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.
Time Frame
Up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Hadigal, Dr.
Organizational Affiliation
Mylan Pharmaceuticals Private Limited
Official's Role
Study Director
Facility Information:
Facility Name
Taichung Veterans General Hospital
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs