Phase
Condition
Hepatitis
Hepatitis B
Treatment
N/AClinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
20 years of age and older, Male or female patients
Patients who show positive HBsAg or has a history of chronic hepatitis B for the lastsix months or more before screening
Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for morethan 48 weeks and are taking TDF at the time of clinical screening
At screening, had HBV DNA < 20 IU/mL
Patients who were explained about the purpose, methods and effects of the clinicaltrial and then, signed a written consent form
Exclusion
Exclusion Criteria:
Patients who have received interferon (including Pegylation formulation) to treatchronic hepatitis for more than 12 months.
Patients who have taken Besifovir
Patients who have experienced hepatitis B virus resistance to antiviral drugs
Patient diagnosed with a malignant tumor within 5 years before screening or relapsedpatient
Patient has history of organ transplantation
Patients who had received the following drugs for the last two months before screening (however, short-term use (less than consecutive 14 days) of these drugs and low-doseaspirin (100 mg, maximally, 300 mg/day) are allowed.)
Nephrotoxic drugs (e.g. Aminoglycosides, Amphotericin B, NSAIDs)
Hepatotoxic drugs (e.g. Erythromycin, Ketoconazole, Rifampin, Fluconazole,Dapsone)
Anticoagulant (e.g. Warfarin)
Patients who are suspected by an investigator to have the level of immunity decreasedamong patients who had been administered with immunosuppressants within 12 monthsbefore screening
Patients who had been administered with long-term general corticosteroids (more thanconsecutive 14 days) at a high dose (more than prednisolone 20 mg daily*) within threemonths before screening (In case of local corticosteroids, an investigator decidesit.)
- It is equal to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg,methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg
Patients who have a past medical history of clinical alcohol or drug abuse within ayear before screening or now are abusers
Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
Patients who have other hepatic diseases (hematochromatosis, Wilson's disease,alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency)except hepatitis B
Patient concerned about the decline in daily activity or not able to understand theobjectives and methods due to the psychiatric problems
Patients who showed Glomerular Filtration Rate (GFR) less than 50 mL/min bycalculating Modification of Diet in Renal Disease (MDRD: 1.86 x phosphocreatine -1.154x age -0.203 (x 0.742 for women)) during screening
Patients who showed alpha-fetoprotein(AFP) more than 50 ng/mL during screening and areestimated to have hepatocellular carcinoma (HCC) through liver/abdomen CT scans
At least one of the following laboratory values during screening
Hemoglobin < 9.0 g/dL
Absolute neutrophil count (ANC) < 1.0 x 10^9 /L (1000 /mm^3)
Platelet count < 75 x 10^9 /L (100 x 10^3 /mm3)
Serum creatinine > 1.5 mg/dL
Serum amylase > 2 x upper limit normal (ULN) and Lipase > 2 x ULN
Total Bilirubin > 2 x ULN
Serum albumin < 28 g/L (2.8 g/dL)
Pregnant women, lactating women, or patients who planned pregnancy during a trialperiod
Patients who participate in other clinical trials or is supposed to do so during thestudy period
Patients who have hypersensitivity to the clinical trial drug in this clinical trial
Patients with genetic problems such as galactose intolerance, Lapp lactase deficiencyor glucose-galactose malabsorption
Patients who are considered to be unacceptable in this study under the opinion of theinvestigator
Study Design
Connect with a study center
Korea University Medical Center
Ansan, Kyounggi-do
Korea, Republic ofActive - Recruiting
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