Status:
COMPLETED
An Study of Efficacy and Safety of Clevudine
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
Eligibility Criteria
Inclusion
- Patients are between 18 and 65, inclusive.
- All the male and female reproductive-aged subjects should use reliable and appropriate contraceptive method from the entrance of screening to at least 3 months within the end of study.
- Hepatitis B virus Early Antigen (HBeAg) positive patient with HBV DNA \>1 x 105 copies/ml, HBeAg negative patient with HBV DNA \>1 x 104 copies/ml within 30 days of baseline.
- Absolute neutrophil count \> 1500 /mm3.
- Alpha fetoprotein within normal laboratory limit at screening.
- Normal electrocardiogram (ECG) or clinically non-significant changes at screening.
- Able to participate and willing to give written informed consent before starting therapy.
- Able and willing to comply with study assessments and restrictions.
- Normal renal function to take Adefovir without any dose modifications; Creatinine clearance must be \>50 ml/min (based on the Cockcroft-Gault equation.
- Exclusion criteria
- Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
- Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
- Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
- Poorly controlled type I or type 2 diabetes mellitus
- Donation or loss more than 400 ml blood within 60 days of baseline.
- Known serious allergies to nucleoside/nucleotide analogs.
- Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT01192854
Start Date
February 1 2010
End Date
May 1 2011
Last Update
May 14 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Xiangya hospital
Changsha, Hunan, China