A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC

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: NCT01263002
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : December 18, 2014
Information provided by:
Bukwang Pharmaceutical

Brief Summary:
An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma

Condition or disease Intervention/treatment Phase
Hepatitis B Associated Hepatocellular Carcinoma Drug: clevudine, Adefovir Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group 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 Associated Hepatocellular Carcinoma
Study Start Date : June 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: clevudine, Adefovir

    Nucleoside-analogue naive patient : Clevudine 30mg qd

    1. Assess the complete virological response(HBV DNA < 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd
    2. Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd
    3. During medication of Clevudine, virological breakthrough : add adefovir 10mg qd
    4. During treatment period, composite virological response : stop the medication and F/U for 2 years
    5. Recurrence after stopping treatment(HBV DNA > 2,000IU/ml) retreat medication at composite virological response.

      • complete virological response: HBV DNA < 60 IU/ml
      • virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously.

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

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

Inclusion Criteria

  1. Patient with chronic HBV DNA and/or with symptoms of liver cirrhosis
  2. Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
  3. Patient is 18 years and older.
  4. Patient is documented to be HBsAg positive for > 6 months.

    • Laboratory report proving HBsAg positive or HBeAg positive for at least six months
    • IgM anti-HBc negative, IgG anti-HBc positive at screening
  5. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
  6. Patient has ALT or AST levels >=40 IU/L
  7. Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
  8. Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
  9. Patient who is classified as NYHA functional classification grade 1-2. (NYHA;New York Heart Association)
  10. 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 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, tenofovir or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient with metastatic malignancy.
  6. Patient with previous liver transplantation
  7. Patient is pregnant or breast-feeding.
  8. Patient has a clinically relevant history of abuse of alcohol or drugs.
  9. Patient use oriental medicine within the previous 2 weeks.
  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): NCT01263002

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical

Responsible Party: Myunghyun Jeong, Bukwang Identifier: NCT01263002     History of Changes
Other Study ID Numbers: CLV-413
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Hepatitis B
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Digestive System Diseases
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents