Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daewoong Pharmaceutical Co. LTD. | INDUSTRY |
The patient who meets the inclusion/exclusion criteria is assigned to Test1 group or Test 2 group or control group randomly.
All subjects take one pill of Viread® Tab. (Tenofovir Disoproxil Fumarate 300mg) once a day for 48 weeks. At the same time, all randomized subjects take two pills of DWPUR001 or Placebo of DWPUR001 twice a day for 48 weeks.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir 300mg qd + DWPUR001 500mg bid | Experimental | Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months |
|
| Tenofovir 300mg qd + DWPUR001 300mg bid | Experimental | Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months |
|
| Tenofovir 300mg qd + DWPUR001 Placebo bid | Placebo Comparator | Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWPUR001 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of normalization of ALT level (≤1× ULN)(%) | At the 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of normalization of ALT level (≤1× ULN)(%) | At the 2, 8, 12, 24, 36, 48 weeks | |
| The change of fibrosis marker(ELF score) compared with the baseline | At the 48 weeks | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
HIV, HCV or HDV infedted patients
Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)
Patients who had suffered from variceal haemorrhage or hepatic encephalopathy
Patients who need/had liver transplant
Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis
Patients who have enteritis and colitis like peptic ulcer or Crohn's disease
Patients who have significant kidney disease, cardiovascular disease, lung disease, nervous disease, self-immune disease, bone disease (ex: osteomalacia, osteopenia, chronic osteomyelitis, osteopsathyrosis, osteochondrosis, multiple fracture) or malignant tumor.
Patients who have systemic infection
Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir
Patients who have the generic problem as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Patients described as below at the time of screening
Patients who had immune- or cytokine-based antiviral agents treatment (ex. Interferon α, Peginterferon α), or immunosuppression therapy (ex. Cyclosporine, Tacrolimus) in 24 weeks at the time of screening
Patients who have to use the contraindication of comedication drugs during clinical trial or can't get the wash-out period
Women of child-bearing potential not using an effective birth control method
Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand the purpose and process of this clinical trial
Patients who participated in other clinical trial in 30 days prior to the enrollment in this study
Patients who were determined inappropriate by the investigator to participate in this study
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Wook Kim, M.D., Ph.D. | Contact | +82-31-847-2719 | cwkim@catholic.ac.kr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan-si | South Korea | |||
| Bundang CHA medical center |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| The change of immunological marker(PD-1, CTLA-4, FoxP3) compared with baseline |
| At the 12, 24, 48 weeks |
| The change of anti-oxidant/anti-inflammatory marker(SOD, MDA, TNF-α) | At the 24, 48 weeks |
| The change of HBV DNA level compared with baseline (IU/mL) | At the 12, 24, 36, 48 weeks |
| Recruiting |
| Bundang |
| South Korea |
| Incheon St. Mary Hospital | Recruiting | Incheon | South Korea |
| Severance Hospital | Recruiting | Seoul | South Korea |
| Ajou University Medical Center | Recruiting | Suwon | South Korea |
| Uijeongbu St. Mary Hospital | Recruiting | Uijongbu | South Korea |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| 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 |
Not provided
Not provided