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

NCT03485534 | Completed Phase 4 DMC

• 1 other identifier: DW_TEN001
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• HBV DNA inhibition

  plasma HBV DNA level of less than 400 copies per milliliter

  48weeks

Secondary Outcomes (1)

• viral suppression

  24weeks

Study Arms (2)

Tenofovir Disoproxil

EXPERIMENTAL

Tenofovir Disoproxil 245mg, a daily dose for 48 weeks

Drug: Tenofovir Disoproxil

Tenofovir Disoproxil Fumarate

PLACEBO COMPARATOR

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

Drug: Tenofovir Disoproxil Fumarate

Interventions

Tenofovir Disoproxil Fumarate DRUG

Viread 300mg

Also known as: Viread

Tenofovir Disoproxil Fumarate

Tenofovir Disoproxil DRUG

Virehepa 245mg

Also known as: Virehepa

Tenofovir Disoproxil

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead
• C&R Research, Inc.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Youngsuk Lim, PHD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label, randomized, Parallel

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 2, 2018
• Study Start: January 23, 2018
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: June 9, 2022

Record last verified: 2022-06

Locations

KR (1)