Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Chronic hepatitis B, hepatitis B e-antigen negative, hepatitis B e-antibody positive, and hepatitis B surface antigen-positive
Hepatitis B e Antigen (HBeAg)-negative at the beginning of TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine)
Received continuous TDF therapy (i.e. TDF monotherapy or combination of TDF + lamivudine or TDF + emtricitabine) treatment for at least 4 years prior to screening. If TDF has been used in combination with lamivudine or emtricitabine, lamivudine or emtricitabine must have been stopped at least 12 weeks prior to screening
Documented hepatitis B virus DNA (HBV DNA) \< 400 copies/mL for at least 3.5 years prior to screening and at screening
ALT within normal range
α-fetoprotein (AFP) \<= 50 ng/mL
Calculated creatinine clearance \>= 70 mL/min by Cockcroft-Gault formula using ideal body weight
\<= 10 kPa on Fibroscan assessment
A negative serum pregnancy test for female subjects
Adult subjects \>= 18 years of age
You may not be if
Known cirrhosis
Evidence of fibrosis \>= Stage 3 (METAVIR) on liver biopsy or Fibroscan \> 10 kPa within 6 months prior to screening
Documentation of confirmed episodes (i.e., 2 consecutive values) of HBV DNA \> 400 copies/mL within 3.5 years prior to screening
History of decompensated liver disease (defined as direct \[conjugated\] bilirubin \> 1.5 x upper limit of normal, prothrombin time (PT) \> 1.5 x upper limit of normal, platelets \< 75,000/mm³, serum albumin \< 3.0 g/dL
History of clinical hepatic decompensation in the judgement of the investigator
Evidence of hepatocellular carcinoma
Significant bone disease (in the judgment of the investigator)
Serological evidence of coinfection with human immunodeficiency virus (HIV), hepatitis C virus, or hepatitis D infection
Known hypersensitivity to TDF, its metabolites, or formulation excipients
Concomitant therapy with disallowed medications
History of malignant disease
Lactating females
Females wishing to became pregnant during the duration of the stud
Subjects participating in another clinical trial can only be enrolled at the discretion of the Medical Monitor
Clareo Health | Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
