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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03485534
Other study ID # DW_TEN001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 23, 2018
Est. completion date November 4, 2019

Study information

Verified date June 2022
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 .


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date November 4, 2019
Est. primary completion date November 4, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years to 69 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tenofovir Disoproxil Fumarate
Viread 300mg
Tenofovir Disoproxil
Virehepa 245mg

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD. C&R Research, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary HBV DNA inhibition plasma HBV DNA level of less than 400 copies per milliliter 48weeks
Secondary viral suppression an HBV DNA level of <400 copies per milliliter 24weeks
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