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An Study of Efficacy and Safety of Clevudine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192854
First Posted: September 1, 2010
Last Update Posted: May 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by Eisai Inc. ( Eisai Co., Ltd. ):

Primary Outcome Measures:
  • Value of log10 hepatitis B virus (HBV) DNA decreases form baseline. [ Time Frame: 48 weeks ]
  • Histological response [ Time Frame: 48 weeks ]

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 ]
  • Percent of patients with normalization of alanine aminotransferase (ALT) at week 48 [ Time Frame: 48 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192854


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

Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT01192854     History of Changes
Other Study ID Numbers: XY3-III-CLV-1001A02.4
First Submitted: August 30, 2010
First Posted: September 1, 2010
Last Update Posted: May 14, 2013
Last Verified: July 2011

Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Clevudine
efficacy
safety
chronic hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Adefovir
Adefovir dipivoxil
Clevudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents