Status:
COMPLETED
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hepatitis B
Chronic Hepatitis B
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.
Eligibility Criteria
Inclusion
- Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
- Able to comply with study regimen and provide written informed consent
Exclusion
- Pregnant or breastfeeding
- Unwilling to use double barrier method of contraception
- Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- Received Hepatitis B therapy in the past
- Use of immunomodulatory therapy in past 12 months
- History of or symptoms of hepatic decompensation or pancreatitis
- Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
- Concurrent medication likely to preclude compliance with schedule of evaluations
- Use of other investigational drugs within 30 days of enrollment
- Abnormal laboratory values during screening
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00412529
Start Date
December 1 2006
Last Update
March 13 2015
Active Locations (8)
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1
Holy Family Hospital_Bucheon
Bucheon,Kyunggi, South Korea
2
Inje University Busan Paik Hospital
Busan, South Korea
3
Yeungnam University Medical Center
Daegu, South Korea
4
Gachon Univ. Gil Medical Center Hospital
Incheon, South Korea