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An Study of Efficacy and Safety of Clevudine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01192854
First received: August 30, 2010
Last updated: May 13, 2013
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis B
 Drug: Clevudine
Drug: Adefovir
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Double-blind, Positive-control, Phase III Trial of the Efficacy and Safety of Clevudine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Histological response [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Percent of patients with normalization of alanine aminotransferase (ALT) at week 48 [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 288
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Clevudine
Clevudine flexible dosages of 30 mg/day
Active Comparator: 2 Drug: Adefovir
Adefovir flexible dosages of 10 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192854

Locations
China, Hunan
Xiangya hospital
Changsha, Hunan, China
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Principal Investigator: Guoping Yang Xiangya hospital
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01192854     History of Changes
Other Study ID Numbers: XY3-III-CLV-1001A02.4
Study First Received: August 30, 2010
Last Updated: May 13, 2013
Health Authority: China: SFDA

Keywords provided by Eisai Inc.:
Clevudine
efficacy
safety
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
2'-fluoro-5-methylarabinosyluracil
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on June 17, 2013