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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01263002
First received: December 17, 2010
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Hepatitis B Associated Hepatocellular Carcinoma
Drug: clevudine, Adefovir
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA levels < 60 IU/mL [ Time Frame: 48 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 33
Study Start Date: June 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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]
  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: NCT01263002

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

No publications provided

Responsible Party: Myunghyun Jeong, Bukwang
ClinicalTrials.gov Identifier: NCT01263002     History of Changes
Other Study ID Numbers: CLV-413
Study First Received: December 17, 2010
Last Updated: July 24, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Hepatitis
Hepatitis A
Hepatitis B
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
2'-fluoro-5-methylarabinosyluracil
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 29, 2014