A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
NCT ID: NCT01264133
Last Updated: 2014-12-18
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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TERMINATED
PHASE4
200 participants
INTERVENTIONAL
2009-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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FACTORIAL
TREATMENT
NONE
Interventions
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Clevudine, Adefovir
Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd
Eligibility Criteria
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Inclusion Criteria
2. Patient is documented to be HBsAg positive for \> 6 months.
3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
4. Patient has ALT levels \>=80 IU/L
5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis \<= 6)
6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion Criteria
2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
7. Patient with previous liver transplantation
8. Patient is pregnant or breast-feeding.
9. Patient has a clinically relevant history of abuse of alcohol or drugs.
10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
11. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
18 Years
ALL
No
Sponsors
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Bukwang Pharmaceutical
INDUSTRY
Responsible Party
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Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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CLV-411
Identifier Type: -
Identifier Source: secondary_id
CLV-411
Identifier Type: -
Identifier Source: org_study_id