An Study of Efficacy and Safety of Clevudine

May 13, 2013 updated by: Eisai Co., Ltd.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Drug: Adefovir
Adefovir flexible dosages of 10 mg/day
EXPERIMENTAL: 1
Drug: Clevudine
Clevudine flexible dosages of 30 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
Time Frame: 48 weeks
48 weeks
Histological response
Time Frame: 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
48 weeks
Percent of patients with normalization of alanine aminotransferase (ALT) at week 48
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Principal Investigator: Guoping Yang, Xiangya Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 13, 2013

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XY3-III-CLV-1001A02.4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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