A Clinical Trials to Evaluate the Efficacy and Safety of Tenofovir With and Without DWPUR001 in Patients With HBV
NCT ID: NCT02966964
Last Updated: 2017-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2015-04-30
2019-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tenofovir 300mg qd + DWPUR001 500mg bid
Tenofovir 300mg qd + DWPUR001 500mg bid for up to 12 months
DWPUR001
Tenofovir 300mg qd + DWPUR001 300mg bid
Tenofovir 300mg qd + DWPUR001 300mg bid for up to 12 months
DWPUR001
Tenofovir 300mg qd + DWPUR001 Placebo bid
Tenofovir 300mg qd + DWPUR001 Placebo bid for up to 12 months
Placebo
Interventions
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DWPUR001
Placebo
Eligibility Criteria
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Inclusion Criteria
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 level≥20,000 IU/mL, or HBeAg-negative and HBV DNA level≥2,000 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 prolonged≤4sec at the time of screening
7. Patients Total bilirubin level≤3.0mg/dL at the time of screening
8. Patients albumin level≥3.0g/dL at the time of screening
9. Patients ELF score≥8.5 at the time of screening
10. Patients who agree with the clinical trial voluntarily and sign on the agreement
Exclusion Criteria
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 α, Peginterferon α), 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
19 Years
69 Years
ALL
No
Sponsors
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Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Uijeongbu St. Mary Hospital
OTHER
Responsible Party
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Chang Wook Kim
Professor
Locations
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Korea University Ansan Hospital
Ansan-si, , South Korea
Bundang CHA medical center
Bundang, , South Korea
Incheon St. Mary Hospital
Incheon, , South Korea
Severance Hospital
Seoul, , South Korea
Ajou University Medical Center
Suwon, , South Korea
Uijeongbu St. Mary Hospital
Uijongbu, , South Korea
Countries
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Central Contacts
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Other Identifiers
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EURECA001
Identifier Type: -
Identifier Source: org_study_id