Status:
COMPLETED
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
Lead Sponsor:
Bukwang Pharmaceutical
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.
Eligibility Criteria
Inclusion
- Patient is 18 years and older.
- Patient is documented to be HBsAg positive for \> 6 months.
- Patient is HBV DNA positive with DNA levels ≥ 1×10\^5 copies/mL within 30days of baseline.
- Patient has ALT levels ≥ 1×ULN
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Exclusion
- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
- Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
- Patient with clinical evidence of decompensated liver disease (Total bilirubin \< 2.0mg/dL, Prothrombin time \< 1.7(INR), Serum albumin≥3.5g/dL)
- Patient is coinfected with HCV, HDV or HIV.
- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient with clinical evidence of hepatocellular carcinoma
- Patient with previous liver transplantation
- Patient is pregnant or breast-feeding.
- Patient has a clinically relevant history of abuse of alcohol or drugs.
- 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.
- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01264354
Start Date
March 1 2010
End Date
February 1 2013
Last Update
December 18 2014
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea