A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

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. Identifier: NCT01264133
Recruitment Status : Terminated
First Posted : December 21, 2010
Last Update Posted : December 18, 2014
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Clevudine, Adefovir Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Study to Evaluate the Efficacy, Safety and Sustained Effect of Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With Chronic Hepatitis B
Study Start Date : September 2009
Primary Completion Date : June 2013
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: Clevudine, Adefovir
    Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd

Primary Outcome Measures :
  1. Proportion of patients with HBV DNA levels < 60 IU/mL [ Time Frame: 48 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patient is 18 years and older.
  2. Patient is documented to be HBsAg positive for > 6 months.
  3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
  4. Patient has ALT levels >=80 IU/L
  5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)
  6. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  2. Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
  3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
  7. Patient with previous liver transplantation
  8. Patient is pregnant or breast-feeding.
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  10. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
  11. 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]

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 identifier (NCT number): NCT01264133

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical

Responsible Party: Byungchul Yoo, Samsung Medical Center Identifier: NCT01264133     History of Changes
Other Study ID Numbers: CLV-411
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

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