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A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-Week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
This study is currently recruiting participants.
Verified by Bukwang Pharmaceutical, March 2008
First Received: March 5, 2008   Last Updated: March 17, 2008   History of Changes
Sponsored by: Bukwang Pharmaceutical
Information provided by: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT00641082
  Purpose

A double-blind randomized, parallel, multicenter with 48 weeks of treatment period. The purpose of this study is to compare the safety and antiviral activity of 48-week Clevudine and Adefovir dipivoxil in HBeAg(-) Chronic Hepatitis B with compensated liver function.


Condition Intervention Phase
HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
Drug: Clevudine
Drug: Adefovir dipivoxil
Phase IV

MedlinePlus related topics: Hepatitis Hepatitis B
Drug Information available for: Adefovir Adefovir dipivoxil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-Week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA below 300copies/mL [ Time Frame: at week 48 ]

Secondary Outcome Measures:
  • The change of HBV DNA from the baseline [ Time Frame: at week 24, 48 ]
  • Proportion of patients with HBV DNA below LOD of RT-PCR [ Time Frame: at week 24, 48 ]
  • ALT normalization rate [ Time Frame: at week 24, 48 ]
  • Proportion of patients with viral breakthrough during 48-week treatment period [ Time Frame: at week 24, 48 ]

Estimated Enrollment: 72
Study Start Date: February 2008
Arms Assigned Interventions
1: Experimental
Clevudine
Drug: Clevudine
30mg for 48 weeks
2: Active Comparator
Adefovir
Drug: Adefovir dipivoxil
10mg for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is between 18 and 60
  • Patient is documented to be HBsAg positive for > 6 months.
  • Patient with compensated hepatic function.
  • Nucleoside treatment-naïve subjects of either gender
  • Patient is HBeAg negative. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(5) copies/mL within 30 days of baseline.
  • Patient has ALT levels which are in the range of ≥2 x ULN and < 10 X ULN
  • Patient who has not a history of ascites, variceal hemorrhage or hepatic encephalopathy.

Exclusion Criteria

  • Patient is currently receiving antiviral or corticosteroid therapy.
  • Patients previously treated with lamivudine, adefovir, entecavir, telbivudine, clevudine, lobucavir, famciclovir or any other investigational nucleoside for HBV infection.
  • Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  • Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
  • Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening visit.
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient with following clinical evidence

    • Decompensated liver cirrhosis (Child class B,C: CPT score ≥ 7) or hepatocellular carcinoma
    • Significant gastrointestinal, renal, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease
  • Previous organ transplantation
  • Patient has a clinically relevant history of abuse of alcohol or drugs.
  • Patient is pregnant or breast-feeding.
  • Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
  • Patient has α-Fetoprotein more than 20ng/mL
  • Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 4,000/mm3 (PMN<1,500/mm3) or Platelet count <80,000/mm3
  • Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641082

Contacts
Contact: Hyo -Suk Lee, MD. PhD 82-2-828-8082 semoon@bukwang.co.kr

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

Study ID Numbers: CLV-401
Study First Received: March 5, 2008
Last Updated: March 17, 2008
ClinicalTrials.gov Identifier: NCT00641082     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:
Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Antiviral Agents
Reverse Transcriptase Inhibitors
Hepatitis
Virus Diseases
Digestive System Diseases
Anti-Retroviral Agents
Hepatitis B, Chronic
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir

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

ClinicalTrials.gov processed this record on May 06, 2009