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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
C&R Research, Inc.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Hepatitis B, Chronic Drug: Tenofovir Disoproxil Fumarate Drug: Tenofovir Disoproxil Phase 4

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label, randomized, Parallel
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tenofovir Disoproxil
Tenofovir Disoproxil 245mg, a daily dose for 48 weeks
Drug: Tenofovir Disoproxil
Virehepa 245mg
Other Name: Virehepa

Placebo Comparator: Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks
Drug: Tenofovir Disoproxil Fumarate
Viread 300mg
Other Name: Viread

Primary Outcome Measures :
  1. HBV DNA inhibition [ Time Frame: 48weeks ]
    plasma HBV DNA level of less than 400 copies per milliliter

Secondary Outcome Measures :
  1. viral suppression [ Time Frame: 24weeks ]
    an HBV DNA level of <400 copies per milliliter

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03485534

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Contact: Mijung Song 02-550-8368

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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Youngsuk Lim, phD    02-550-8368   
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
C&R Research, Inc.
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Principal Investigator: Youngsuk Lim, PHD Asan Medical Center
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Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT03485534    
Other Study ID Numbers: DW_TEN001
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents