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Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients (HBV)

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
  • HBeAg negative and HBeAb positive at screening

Exclusion Criteria:

  • Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
  • Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
  • Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
  • Significant renal, cardiovascular, pulmonary, or neurological disease
  • currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tenofovir Disoproxil

Tenofovir Disoproxil Fumarate

Arm Description

Tenofovir Disoproxil 245mg, a daily dose for 48 weeks

Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks

Outcomes

Primary Outcome Measures

HBV DNA inhibition
plasma HBV DNA level of less than 400 copies per milliliter

Secondary Outcome Measures

viral suppression
an HBV DNA level of <400 copies per milliliter

Full Information

First Posted
March 27, 2018
Last Updated
June 8, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborators
C&R Research, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03485534
Brief Title
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
Acronym
HBV
Official Title
Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 23, 2018 (Actual)
Primary Completion Date
November 4, 2019 (Actual)
Study Completion Date
November 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborators
C&R Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate. In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
Detailed Description
Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase. The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open-label, randomized, Parallel
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tenofovir Disoproxil
Arm Type
Experimental
Arm Description
Tenofovir Disoproxil 245mg, a daily dose for 48 weeks
Arm Title
Tenofovir Disoproxil Fumarate
Arm Type
Placebo Comparator
Arm Description
Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate
Other Intervention Name(s)
Viread
Intervention Description
Viread 300mg
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil
Other Intervention Name(s)
Virehepa
Intervention Description
Virehepa 245mg
Primary Outcome Measure Information:
Title
HBV DNA inhibition
Description
plasma HBV DNA level of less than 400 copies per milliliter
Time Frame
48weeks
Secondary Outcome Measure Information:
Title
viral suppression
Description
an HBV DNA level of <400 copies per milliliter
Time Frame
24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months. HBeAg negative and HBeAb positive at screening Exclusion Criteria: Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study. Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) Significant renal, cardiovascular, pulmonary, or neurological disease currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Youngsuk Lim, PHD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients

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