Last updated on February 2018

A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: chronic hepatitis b
  • Age: Between 19 - 69 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Patients at the age in between 19 and 69 years at the time of agreement
  2. Patients who had HBsAg-positive at least within 24 weeks or had a diagnosis with chronic hepatic disease by image test within 24 weeks from the time of screening.
  3. Patients who had HBeAg-positive and HBV DNA level20,000 IU/mL, or HBeAg-negative and HBV DNA level2,000 IU/mL
  4. Patients never treated with Tenofovir
  5. Patients whose ALT level is more than 2 times of UNL at the time of screening
  6. Patients prothrombin time prolonged4sec at the time of screening
  7. Patients Total bilirubin level3.0mg/dL at the time of screening
  8. Patients albumin level3.0g/dL at the time of screening
  9. Patients ELF score8.5 at the time of screening
  10. Patients who agree with the clinical trial voluntarily and sign on the agreement

Exclusion Criteria:

  1. HIV, HCV or HDV infedted patients
  2. Patients who have abnormal liver function caused by other diseases (e.g. hematochromatosis, Wilson's disease, alcoholic hepatitis, Nonalcoholic steatohepatitis, alpha 1 antitrypsin deficiency)
  3. Patients who had suffered from variceal haemorrhage or hepatic encephalopathy
  4. Patients who need/had liver transplant
  5. Patients who have severe biliary obstruction, fulminant hepatic failure, radio-opacity gallstone, non-functional gall bladder, acute cholecystitis, Lactic acidosis/ adiposis
  6. Patients who have enteritis and colitis like peptic ulcer or Crohn's disease
  7. 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.
  8. Patients who have systemic infection
  9. Patients who have hypersensitivity to ursodeoxycholic acid or Tenofovir
  10. Patients who have the generic problem as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  11. Patients described as below at the time of screening
    • Hb<8g/dL
    • eGFR<60mL/min/1.73m2
    • AFP level>200ng/mL or had a diagnosis with hepatocellular carcinoma based on the radiology result within 24 weeks
  12. Patients who had immune- or cytokine-based antiviral agents treatment (ex. Interferon , Peginterferon ), or immunosuppression therapy (ex. Cyclosporine, Tacrolimus) in 24 weeks at the time of screening
  13. Patients who have to use the contraindication of comedication drugs during clinical trial or can't get the wash-out period
  14. Women of child-bearing potential not using an effective birth control method
  15. Patients who have psychiatric disorders or drug or alcohol abuse, so can't understand the purpose and process of this clinical trial
  16. Patients who participated in other clinical trial in 30 days prior to the enrollment in this study
  17. Patients who were determined inappropriate by the investigator to participate in this study

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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