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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hepatitis B, Chronic

Treatments: Drug: Tenofovir Disoproxil Fumarate; Drug: Tenofovir Disoproxil

Study type: Interventional

Funder types: Industry

Identifiers

NCT03485534

DW_TEN001

Details and patient eligibility

About

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

Full 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 .

Enrollment: 189 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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189 participants in 2 patient groups, including a placebo group

Tenofovir Disoproxil

Experimental group

Description:

Tenofovir Disoproxil 245mg, a daily dose for 48 weeks

Treatment:

Drug: Tenofovir Disoproxil

Tenofovir Disoproxil Fumarate

Placebo Comparator group

Description:

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

Treatment:

Drug: Tenofovir Disoproxil Fumarate