Status:
COMPLETED
PegIntron Versus Adefovir in the Treatment of Chronic Hepatitis B (CHB) e Antigen Positive Patients in Taiwan (P04498/MK-4031-278)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B, Chronic (CHB)
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This is an open label, randomized, comparative, multi-center study. Subjects will be screened within 2 weeks prior to study entry to establish eligibility. Subjects who meet all the selection criteria...
Eligibility Criteria
Inclusion
- Adult male or female, 18 to 70 years of age.
- Documented positive serum hepatitis B surface antigen (HBsAg) for a minimum of 6 months prior to randomization.
- Hepatitis B virus (HBV) replication and hepatitis documented by:
- Serum HBV DNA (Hepatitis B Virus Deoxyribonucleic acid) \>= 10\^5 copies/mL within 3 months prior to entry
- Positive serum hepatitis B e antigen (HBeAg) within 3 months prior to entry
- Documented presence of ALT (Alanine Aminotransferase) twice (1 month apart) within 3 months prior to entry (2 to 10 folds above the upper normal level)
- Liver biopsy finding shows evidence of chronic hepatitis without liver cirrhosis, document acceptable if no anti-HBV treatment within 1 year prior to randomization
- Naïve or exposed to lamivudine (3 months treatment-free interval prior to randomization)
- Adequate renal function (creatinine within normal upper limit).
- Compensated liver disease with certain minimum hematological and serum biochemical criteria.
- Thyroid stimulating hormone (TSH) and free T4 within normal ranges.
- Negative antibody to hepatitis C and hepatitis D.
- Negative antibody to human immunodeficiency virus.
- Negative evidence for hepatocellular carcinoma by alfa-fetoprotein and ultrasound within 1 month prior to randomization.
Exclusion
- Women who are pregnant or nursing.
- Prior treatment for hepatitis with any interferon or adefovir, or other investigational anti-virus agents.
- Prior treatment for hepatitis with immunomodulatory drug within 2 years prior to randomization.
- Suspected hypersensitivity to interferon or adefovir.
- Liver cirrhosis.
- History of severe psychiatric disease, especially depression.
- Concurrent malignancies (including hepatocellular carcinoma).
- Unstable or significant cardiovascular diseases.
- Prolonged exposure to known hepatotoxins.
- History of thyroid disease poorly controlled on prescribed medication.
- Poorly controlled diabetes mellitus.
- Have suspected or confirmed significant hepatic disease from an etiology other than HBV.
- Severe renal disease or myeloid dysfunction.
- History of organ transplantation other than cornea and hair transplant.
- Any medical condition requiring chronic systemic administration of steroids.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00371761
Start Date
September 1 2006
End Date
February 1 2009
Last Update
April 6 2017
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