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

NCT05355467 | Completed Phase 4

• 1 other identifier: Mylan-Ricovir-TW-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Assessment of the rates of virological recurrence of HBV

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

  Week 24

Secondary Outcomes (3)

• Comparison of the HBV DNA levels between Ricovir® group and historical control group

  Week 24

• Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.

  Week 24

• Monitoring of Safety profile for subjects in Ricovir® group

  Up to 24 weeks

Study Arms (2)

Ricovir® group

EXPERIMENTAL

Drug: Tenofovir disoproxil fumarate

Historical Control Group

OTHER

Other: Historical Data

Interventions

Tenofovir disoproxil fumarate DRUG

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

Ricovir® group

Historical Data OTHER

Historical Data

Historical Control Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Mylan (Taiwan) Ltd: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sanjay Hadigal, Dr.

  Mylan Pharmaceuticals Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 2, 2022
• Study Start: August 21, 2019
• Primary Completion: July 13, 2021
• Study Completion: July 13, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

TW (1)