Status:
UNKNOWN
Comparison of Telbivudine Plus Adefovir With Lamivudine Plus Adefovir for the Treatment of Lamivudine-resistant Chronic Hepatitis B at 52 Weeks: A Pilot Study
Lead Sponsor:
Korea University
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Lamivudine had been widely used for treatment-naïve chronic hepatitis B patients. However, development of antiviral resistance has been known as the major drawback: Incidence of lamivudine resistance ...
Eligibility Criteria
Inclusion
- HBeAg positive or negative chronic hepatitis B patients (positive HBsAg more than 6 months)
- Age ≥ 18 years old, and ≤70 years old
- Previous treatment with lamivudine more than 6 months
- Being on lamivudine at the time of screening
- Confirmed genotypic resistance to lamivudine by RFMP (rtM204V or I)
- Presence of virologic breakthrough ≥1 log increase of HBV DNA above na dir)
- HBV DNA ≥ 20,000 IU/mL
- Patient willing to give an informed consent (If patient is \<20 years old, the parent or legal guardian also need to give an informed consent)
Exclusion
- Out of inclusion criteria
- Presence of adefovir resistance (rtA181T or V, rtN236T) by RFMP assay
- Laboratory abnormalities as follows at screening: AFP\>100 ng/mL, serum phosphorous level\<2.4 mg/dL, serum creatinine level\> 1.5 mg/dL or creatinine clearance \< 50 mL/min
- Patient with a history of decompensated liver disease: Any patients with a history of ascites, hepatic encephalopathy, variceal bleeding, jaundice, or CTP\>7 points should be excluded.
- History of treatment with nucleos(t)ide analogues other than lamivudine more than 4 weeks
- History of immune modulatory drugs (interferon, thymosin-alfa) within 24 weeks of screening
- Liver transplant patient
- Patient co-infected with HIV, HCV, or HDV
- Patient with metabolic or genetic liver disease that may affect serum ALT level
- Habitual alcohol consumption (\>140 g/week for male, \>70 g/week for female)
- Patient not able to stop drugs that may affect ALT or HBV DNA level during study periods (ie. Steroid, immune-suppressants, non-steroidal anti-inflammatory drugs, acetaminophen,)
- Pregnant or lactating woman
- Menstruating woman unwilling to use appropriate methods of contraception (ie. Condom, oral contraceptives, tubal ligation)
- Patient with hepatocellular carcinoma (treated or not treated)
- Patient with any untreated malignancy
- Patient with history of malignancy cured within 5 years of screening
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01804387
Start Date
May 1 2011
End Date
May 1 2014
Last Update
March 5 2013
Active Locations (1)
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1
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea, 425-707