Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients (HBV)
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|ClinicalTrials.gov Identifier: NCT03485534|
Recruitment Status : Unknown
Verified March 2018 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was: Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: Tenofovir Disoproxil Fumarate Drug: Tenofovir Disoproxil||Phase 4|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open-label, randomized, Parallel|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 19, 2017|
|Estimated Primary Completion Date :||October 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Experimental: Tenofovir Disoproxil
Tenofovir Disoproxil 245mg, a daily dose for 48 weeks
Drug: Tenofovir Disoproxil
Other Name: Virehepa
Placebo Comparator: Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks
Drug: Tenofovir Disoproxil Fumarate
Other Name: Viread
- HBV DNA inhibition [ Time Frame: 48weeks ]plasma HBV DNA level of less than 400 copies per milliliter
- viral suppression [ Time Frame: 24weeks ]an HBV DNA level of <400 copies per milliliter
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485534
|Contact: Mijung Songemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Youngsuk Lim, phD 02-550-8368 firstname.lastname@example.org|
|Principal Investigator:||Youngsuk Lim, PHD||Asan Medical Center|