None listed
Conditions
Interventions
Drug : Approximately 174 patients who completes IN-US-174-0202/0205 studies will be randomized in a 1:1 ratio (case:control) to receive either TAF 25 mg QD oral and TDF 300 mg QD oral.
At randomizatio
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures 2. Male or female, 20 to 80 years of age 3. Compensated liver disease (Child-Pugh score <8) 4. HBsAg(Hepatitis B surface Antigen) positive at least 6 months or more 5. HBeAg(Hepatitis B Virus e antigen) positive or negative 6. Confirmation of Adefovir resistance mutation (rtA181V, rtA181T or rtN236T) or Entecavir resistance mutation (rt184, rtS202, or rtM250) 7. Patient who has maintained Tenofovir Disoproxil Fumarate(TDF) sole treatment for more than 96 weeks is taking Tenofovir Disoproxil Fumarate(TDF) at the time of clinical trial screening. 8. Patient is willing and able to comply with all study requirements
Exclusion criteria
Exclusion criteria: 1. Co-infection with HCV(Hepatitis C Virus), HDV(Hepatitis D(elta) Virus), HIV(Human Immunodeficiency Virus) 2. Abusing alcohol (more than 40 g/day) or illicit drugs 3. Abnormal hematological and biochemical parameters, including: 1) serum bilirubin >3 mg/dL 2) prothrombin time(INR) >1.5 3) serum albumin <2.8 g/dL 4) ascites, encephalopathy or variceal hemorrhage 5) Child-Pugh score =8 4. Received interferon or other immunomodulatory treatment for HBV(Hepatitis B virus) infection in the 12 months before screening for this study 5. Medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agent 6. Received solid organ or bone marrow transplant 7. Known hypersensitivity to study drugs, metabolites, or formulation excipients 8. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study or unable to comply with dosing requirements 9. Use of investigational agents within 3 months of screening, unless allowed by the Sponsor or Investigator 10. A history of hepatocellular carcinoma (HCC) within 5 years of screening 11. A history treated malignancy (other than hepatocellular carcinoma (HCC)) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years 12. Participation in another investigational drug trial related antiviral or immunosuppressive agent. 13. Pregnant or breastfeeding or willing to be pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with virologic response | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with virologic response;The proportion of patients with HBV DNA less than 15 IU/mL | — |
Countries
Korea, Republic of
Contacts
Public ContactDalnim Seo
Asan Medical Center
Outcome results
None listed