An Study of Efficacy and Safety of Clevudine

Eisai

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis B

Treatments: Drug: Adefovir; Drug: Clevudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192854

XY3-III-CLV-1001A02.4

Details and patient eligibility

About

Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B

Enrollment: 288 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Patients are between 18 and 65, inclusive.
2. 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.
3. 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.
4. Absolute neutrophil count > 1500 /mm3.
5. Alpha fetoprotein within normal laboratory limit at screening.
6. Normal electrocardiogram (ECG) or clinically non-significant changes at screening.
7. Able to participate and willing to give written informed consent before starting therapy.
8. Able and willing to comply with study assessments and restrictions.
9. 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

1. Subjects coinfected with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV) or hepatitis E virus
2. Patients previously or currently treated with approved and investigational nucleosides (e.g.: lamivudine, adefovir. entecavir, lobucavir, famciclovir, tenofovir, telbivudine) for any duration.
3. Other chronic hepatic disease. e.g. chronic alcoholism. Wilson's disease.
4. Poorly controlled type I or type 2 diabetes mellitus
5. Donation or loss more than 400 ml blood within 60 days of baseline.
6. Known serious allergies to nucleoside/nucleotide analogs.
7. Subjects who are pregnant, nursing, or unwilling to use appropriate form of contraception.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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288 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Clevudine

2

Active Comparator group

Treatment:

Drug: Adefovir