Chronic Hepatitis B
Conditions
Keywords
tenofovir disoproxil fumarate
Brief summary
This is an open-label, single arm cohort study to see efficacy and safety of tenofovir disoproxil fumarate (TDF) in naïve chronic hepatitis B, retrospectively and prospectively both.
Interventions
DRUGtenofovir disoproxil fumarate
Sponsors
Gilead Sciences
Wonkwang University
Soonchunhyang University Hospital
Chungnam National University Hospital
Konyang University Hospital
Myeong Jun Song
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. 2. Adult male and non-pregnant, non-lactating female subjects, 19 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal). 3. Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) 4. Chronic hepatitis B with the following: * HBeAg-positive and HBeAb negative at Screening * Screening HBV DNA ≥ 1x 105 copies/mL * Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR * HBeAg-negative and HBeAb positive at Screening * Screening HBV DNA ≥ 1x 104 copies/mL * Screening serum ALT level ≥ ×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR * Cirrhosis at Screening * Screening HBV DNA ≥ 1x 104 copies/mL in HBeAg negative or * Screening HBV DNA ≥ 1x 105 copies/mL in HBeAg positive * Screening serum ALT level ≥ ×ULN and ≤ 10 ×ULN (by center laboratory range) 5. A patient who treating with TDF as a treatment-naïve for Hepatitis B. Treatment naïve subjects defined as no history of antiviral therapy or \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir 6. Decompensated liver cirrhosis defined based on a Child-Turcotte-Pugh (CTP) score ≥ 7 (Child B and C) or presence with at least one episode of ascites, jaundice, hepatic encephalopathy or variceal bleeding 7. Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit 8. Must be willing and able to comply with all study requirements.
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 | week 48 | proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 |
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96 | Week 96 | proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96 | Week 48 and 96 | The proportion of the serological response (loss of HBeAg and seroconversion to HBeAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96 |
| The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96 | Week 48 and 96 | The proportion of the serological response (loss of HBsAg and seroconversion to HBsAb) of TDF for the treatment of chronic hepatitis B at Week 48 and 96 |
| The change from baseline in the decline of HBV DNA at every visits | week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | The change from baseline in the decline of HBV DNA at every visits |
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits | week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144 | The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at every visits |
| The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96 | Week 48 and 96 | The incidence of resistance of TDF among patients showing virological breakthrough at week 48 and 96. Virological Breakthrough defined as any increase in serum HBV DNA by \>1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result |
| The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96 | Week 48 and 96 | The proportion of improvement of liver function including Child Score, MELD score at Week 48 and 96 |
| The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96 | Week 48 and 96 | The proportion of improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96 |
| The proportion of patients showing virological breakthrough at week 48 and 96 | Week 48 and 96 | The proportion of patients showing virological breakthrough at week 48 and 96. Virological Breakthrough defined as any increase in serum HBV DNA by \>1 log10 from nadir or redetection of serum HBV DNA at levels ≥10-fold the lower limit of detection of the HBV DNA assay after having an undetectable result |
| The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96 | Week 48 and 96 | The proportion of the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96 |
Countries
South Korea
Outcome results
None listed