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Completed

NCT Number: NCT01192854

An Study of 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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Clevudine

Drug

Clevudine flexible dosages of 30 mg/day

Adefovir

Drug

Adefovir flexible dosages of 10 mg/day

Primary outcomes

  1. Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.

    Time frame: 48 weeks

  2. Histological response

    Time frame: 48 weeks

Secondary outcomes

  1. 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

  2. Percent of patients with normalization of alanine aminotransferase (ALT) at week 48

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2010
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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