Status:
UNKNOWN
TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR)
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Conditions:
Hepatitis B
Fibrosis and Cirrhosis of Liver
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
A total of 80 adult chronic hepatitis B patients with advanced liver fibrosis (including fibrosis stage 3 and cirrhosis), who are currently on nucleot(s)ide analogs (except tenofovir alafenamide) ther...
Detailed Description
Study Overview Dosage regimen: Patients of CHB with advanced fibrosis and partial virological response to NUCs will be considered eligible for the present study. The enrollment will be up to the phys...
Eligibility Criteria
Inclusion
- Male or female, age ≥20 years
- CHB diagnosis confirmed by positive HBsAg or HBV DNA for more than 6 months, or documented history of CHB in medical record before initiation of NUC therapy.
- Currently maintained on nucleot(s)ide analogues (except TAF) therapy for more than one year, with detectable HBV DNA after 52 weeks of therapy, detectable HBV DNA within 3-6 months prior to screening, and remains detectable HBV DNA at screening.
- Patients with liver fibrosis stage 3 (defined as Metavir fibrosis stage 3 by liver biopsy, or fibrosis-4 score 3.25 \~ 6.49, or ARFI 1.80 \~ 1.99 m/s, or Fibroscan 9.5\~12.4 kPa), or cirrhosis (defined as Metavir fibrosis stage 4 by liver biopsy, or APRI \>2, or fibrosis-4 score ≥ 6.5, or ARFI ≥ 2.0 m/s, or Fibroscan ≥12.5 kPa, or image diagnosis with splenomegaly or esophageal/gastric varices) at the initiation of prior NUC therapy or during the prior NUC therapy. The liver biopsy should be within 5 years, or during the prior NUC therapy and other non-invasive assessments should be within 6 months at the initiation of NUC therapy or during the prior NUC therapy.
- Estimated creatinine clearance \> 15 ml/min (using the Cockcroft-Gault method) within 6 months prior to screening. (Note: multiply estimated rate by 0.85 for women).
- Willing and able to provide informed consent
- Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
Exclusion
- Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
- Previous recipient of a liver transplant
- Co-infection with human immunodeficiency virus (HIV) or hepatitis C (HCV) or hepatitis D (HDV)
- Severe or uncontrolled comorbidities, determined by the Investigator.
- Known history of serum albumin level \<3 g/dL, or total bilirubin level \>3 mg/dL, or presence of ascites.
- Known history of hepatic encephalopathy, and/or variceal bleeding.
- Malignancy history including hepatocellular carcinoma, except cancers curable by surgical resection (e.g. basal cell skin cancer and squamous cell cancer within 5 yrs of screening).
- On any of the disallowed concomitant medications listed in the prior and concomitant medications list (pg. 11). Subjects on prohibited medications who are otherwise eligible will need a wash out period of at least 30 days prior to the Screening.
- Males and females of reproductive potential who are unwilling to use "effective" protocol-specified method(s) of contraception during the study.
- Current substance or alcohol abuse judged by the investigator to potentially interfere with subject compliance.
- Any other clinical conditions that, in the opinion of the Investigator, would make the subject unsuitable or unable to comply with any of the study procedures
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03798119
Start Date
February 25 2019
End Date
August 31 2021
Last Update
April 26 2019
Active Locations (1)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan, 807