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 has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00641082
First received: March 5, 2008
Last updated: April 24, 2012
Last verified: April 2012
  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 4

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 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

Resource links provided by NLM:


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 ]

Enrollment: 43
Study Start Date: February 2008
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clevudine
Drug: Clevudine
30mg for 48 weeks
Other Name: Levovir
Active Comparator: 2
Adefovir
Drug: Adefovir dipivoxil
10mg for 48 weeks
Other Name: Hepsera

  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-naÃ-ve 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 100ng/mL
  • Patient has Hemoglobin <11g/dL (Male), 10g/dL (Female) or WBC count < 3,500/mm3 (PMN<1,500/mm3) or Platelet count <50,000/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641082

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

No publications provided

ClinicalTrials.gov Identifier: NCT00641082     History of Changes
Other Study ID Numbers: CLV-401
Study First Received: March 5, 2008
Last Updated: April 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on October 23, 2014