Status:
COMPLETED
Switching From TDF to TAF vs. Maintaining TDF in Chronic Hepatitis B With Resistance to Adefovir or Entecavir.
Lead Sponsor:
Young-Suk Lim
Collaborating Sponsors:
Samsung Medical Center
Korea University Guro Hospital
Conditions:
Chronic Hepatitis b
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
Treatment of CHB patients with genotypic resistance to NUCs has been problematic due to the lack of data from randomized trials. Recently, two randomized trials comparing the efficacy of TDF monothera...
Detailed Description
Study objectives The objective of this study is to evaluate whether efficacy, safety, and tolerability (including bone and renal outcomes) were non-inferior in patients switched to a tenofovir alafena...
Eligibility Criteria
Inclusion
- All of below
- Patient must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- Male or female, 20 to 80 years of age
- Compensated liver disease (Child-Pugh score \< 8)
- HBsAg positive at least 6 months or more
- HBeAg positive or negative
- Confirmation of ETV resistance mutation (rt184, rtS202, or rtM250) at the enrollment of IN-US-174-0202 study, or ADV resistance mutation (rtA181V, rtA181T or rtN236T) at the enrollment of IN-US-174-0205 study
- Completion of the week 240 visit in studies IN-US-174-0202 or 0205 study and maintained on TDF 300 mg QD
- Patient is willing and able to comply with all study requirements
Exclusion
- Any of below
- Co-infection with HCV, HDV, HIV
- Abusing alcohol (more than 40 g/day) or illicit drugs
- 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 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 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
- 13\. Pregnant or breastfeeding or willing to be pregnant
Key Trial Info
Start Date :
October 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2021
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03241641
Start Date
October 26 2017
End Date
March 25 2021
Last Update
March 29 2021
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea, 05505