Status:
COMPLETED
Evaluate the Efficacy and Safety to Tenofovir Disoproxil in Chronic Hepatitis B Patients
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Collaborating Sponsors:
C&R Research, Inc.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
19-69 years
Phase:
PHASE4
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. ...
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) polymera...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2019
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT03485534
Start Date
January 23 2018
End Date
November 4 2019
Last Update
June 9 2022
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea