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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Wonkwang University | OTHER |
| Soonchunhyang University Hospital | OTHER |
| Chungnam National University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tenofovir disoproxil fumarate monotherapy | a group which treated with tenofovir disoproxil fumarate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenofovir disoproxil fumarate | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 | proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 48 | week 48 |
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96 | proportion of subjects with plasma HBV DNA levels below 116 copies/mL at Week 96 | Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with plasma HBV DNA levels below 116 copies/mL 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 the biochemical (alanine aminotransferase normalization) response of TDF for the treatment of chronic hepatitis B at Week 48 and 96 |
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Inclusion Criteria:
Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
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).
Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
Chronic hepatitis B with the following:
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
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
Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 6 months prior to the baseline visit
Must be willing and able to comply with all study requirements.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria are not to be enrolled in the study.
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Secondary and Tertiary hospital
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| Name | Affiliation | Role |
|---|---|---|
| Myeong Jun Song, Ph.D. M.D. | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea, Daejeon St.Mary's Hosptial | Junggu | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30725293 | Derived | Kwon JH, Song MJ, Jang JW, Bae SH, Choi JY, Yoon SK, Kim HY, Kim CW, Song DS, Chang UI, Yang JM, You CR, Choi SW, Lee HL, Lee SW, Han NI, Nam SW, Kim SG, Kim YS, Kim SH, Lee BS, Lee TH, Cho EY. Efficacy and Safety of Tenofovir Disoproxil Fumarate in Treatment-Naive Patients with Chronic Hepatitis B in Korea. Dig Dis Sci. 2019 Jul;64(7):2039-2048. doi: 10.1007/s10620-019-05489-7. Epub 2019 Feb 6. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| OTHER |
| Konyang University Hospital | OTHER |
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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 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 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 HBsAg and seroconversion to HBsAb) 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 change from baseline in the decline of HBV DNA at every visits | 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 proportion of patients showing virological breakthrough at 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 | Week 48 and 96 |
| The incidence of resistance of TDF among patients showing virological breakthrough at 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 | Week 48 and 96 |
| The proportion of improvement of liver function including Child Score, Model for End-stage Liver Disease (MELD) score at Week 48 and 96 | The proportion of improvement of liver function including Child Score, MELD score 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 improvement of Fibrosis marker including Aspartate aminotransferase to Platelet Ratio Index(APRI) at Week 48 and 96 | Week 48 and 96 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |