An Study of Efficacy and Safety of Clevudine

Chronic Hepatitis B Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192854
• Other study ID #: XY3-III-CLV-1001A02.4
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2010
• Last updated: May 13, 2013
• Start date: February 2010
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: SFDA
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Clevudine
Clevudine flexible dosages of 30 mg/day
• Adefovir
Adefovir flexible dosages of 10 mg/day

Locations

Country	Name	City	State
China	Xiangya hospital	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.		48 weeks	No
Primary	Histological response		48 weeks	No
Secondary	Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.		48 weeks	No
Secondary	Percent of patients with normalization of alanine aminotransferase (ALT) at week 48		48 weeks	No