CClinicalTrials.gg
Sign In
CompletedNCT03485534HBVUpdated Jun 9, 2022

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

A Phase 4 interventional study of Tenofovir Disoproxil Fumarate and Tenofovir Disoproxil in Hepatitis B, Chronic, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2022-06-09.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
189
Allocation
Randomized
Ages
19 Years to 69 Years
Sex
All
01

Study 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

Read the 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 .

02

Conditions studied

  • Hepatitis B, Chronic
03

Who can participate

Ages eligible
19 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
189 participants (actual)

Study arms

  • Experimental
    Tenofovir Disoproxil

    Tenofovir Disoproxil 245mg, a daily dose for 48 weeks

    Drug: Tenofovir Disoproxil

  • Placebo comparator
    Tenofovir Disoproxil Fumarate

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

    Drug: Tenofovir Disoproxil Fumarate

Interventions

  • DrugTenofovir Disoproxil Fumarate

    Viread 300mg

    Also known as: Viread

  • DrugTenofovir Disoproxil

    Virehepa 245mg

    Also known as: Virehepa

05

What researchers measure

Primary outcomes

  1. HBV DNA inhibition

    plasma HBV DNA level of less than 400 copies per milliliter

    Time frame: 48weeks

Secondary outcomes

  1. viral suppression

    an HBV DNA level of \<400 copies per milliliter

    Time frame: 24weeks

06

Study locations

1 site
  • Asan Medical Center
    Seoul, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485534
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Collaborators
C&R Research, Inc.
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Jan 23, 2018
Primary completion
Nov 4, 2019
Completion
Nov 4, 2019
Last update
Jun 9, 2022

Study contacts

Youngsuk Lim, PHD
principal investigator · Asan Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Daewoong Pharmaceutical Co. LTD.

Start the discussion