Phase
Condition
Hepatitis B
Hepatitis
Liver Disorders
Treatment
N/AClinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients over the age of 20 years old
Patients who show positive HBsAg or has a history of chronic hepatitis B for the lastsix months or more before screening
Patients who have not received interferon (including Pegylation formulation) to treatchronic hepatitis and antiviral agents for more than 12 weeks.
Patients who showed positive HBsAg during screening
Patients who showed HBV DNA measured by COBAS TaqManTM HBV Test more than 1x105copies/mL (17,241 IU/mL) in case of positive HBeAg during screening, or who showed HBVDNA measured by COBAS TaqManTM HBV Test more than 1x104 copies/mL (1,724 IU/mL) incase of negative HBeAg
Patients who showed ALT more than 1.2 times, or less than 10 times of the upper limitin the normal range during screening
Patients who were explained about the purpose, methods and effects of the clinicaltrial and then, signed a written consent form.
Male and female patients of childbearing age who can use double contraceptionacknowledged* during a trial period * Double contraception acknowledged meanscombination of barrier contraception (condom, diaphragm, etc.) and other contraception (sterilization operation, intrauterine contraceptive device, oral contraceptive drug,other hormone delivery system, contraceptive cream, jelly or foam, etc.).
Exclusion
Exclusion Criteria:
Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiencyvirus (HIV)
Patients with a uncompensated liver disease who have at least one of the followingvalues or signs during screening
Total bilirubin > 2 x ULN
Prothrombin time delayed more than three seconds compared to the normal value
Serum Albumin < 30 g/L (3 g/dL)
A medical history of ascites, jaundice, hemorrhage by varix, hepaticencephalopathy, or other signs of liver function loss
- At least one of the following laboratory values during screening
Hemoglobin < 9.0 g/dL
Absolute neutrophil count (ANC) < 1.5 x 109 /L (1500 /mm3)
Platelet count < 100 x 109 /L (100 x 103 /mm3)
Serum creatinine > 1.5 mg/dL
Serum amylase > 2 x ULN and Lipase > 2 x ULN
Patients who showed GFR less than 50 mL/min by calculating MDRD (Modification of Dietin Renal Disease: 1.86 x PCr -1.154 x 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
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 six 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 2.4mg.
Patients who were diagnosed as a malignant tumor within five years before screening orhave a relapse of a malignant tumor (In case of a benign tumor, if an investigatordecides that it does not affect the progress of the clinical trial during a trialperiod, the patients can be registered.)
Patients who are scheduled to participate in other clinical trial after registered inthis clinical trial, or had been participated in other clinical trial within threemonths before registered in this clinical trial
Pregnant women, lactating women, or patients who planned pregnancy during a trialperiod
Patients who have hypersensitivity to the clinical trial drug in this clinical trial
Patients who have a past medical history of clinical alcohol or drug abuse within ayear before screening or now are abusers
Patients who have a severe disease, such as liver diseases, heart failure, renalfailure, and pancreatitis, decided by an investigator to have an effect on thisclinical trial
Patients who have other hepatic diseases (hematochromatosis, Wilson's disease,alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency)except hepatitis B
Patients who received an organ transplant
Persons who are possible to decline daily function due to a mental disease or patientswho are not able to understand the purpose and methods of this clinical trial
Patients who are decided by an investigator as unsuitable for conducting this clinicaltrial
Study Design
Study Description
Connect with a study center
Soonchunhyang University Hospital
Cheonan, Chungchoengnam-do
Korea, Republic ofSite Not Available
Hallym University Medical Center
ChunCheon, Kangwon-do
Korea, Republic ofSite Not Available
Wonju Sevrerance Christian Hospital
Wonju, Kangwon-do
Korea, Republic ofSite Not Available
Korea University Medical Center
Ansan, Kyounggi-do
Korea, Republic ofSite Not Available
Hanyang University Guri Hospital
Guri, Kyunggi-do
Korea, Republic ofSite Not Available
Ajou University Medical Center
Suwon,, Kyunggi-do
Korea, Republic ofSite Not Available
Kyungpook National University Hospital
Daegu,
Korea, Republic ofSite Not Available
Chungnam National University Hospital
Daejeon,
Korea, Republic ofSite Not Available
Inha University Hospital
Incheon,
Korea, Republic ofSite Not Available
Inje University Busan Paik Hospital
Pusan,
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
Gangnam Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Korea University Medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Boramae medical Center
Seoul,
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul,
Korea, Republic ofSite Not Available
Severance Hospital of Yonsei University
Seoul,
Korea, Republic ofSite Not Available
Soonchunhyang University Hospital
Seoul,
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul,
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Vincent's Hospital
Seoul,
Korea, Republic ofSite Not Available
Ulsan University Hospital,
Ulsan,
Korea, Republic ofSite Not Available
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