A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Bukwang Pharmaceutical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00672867
First received: May 2, 2008
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.


Condition Intervention Phase
Patients With LC-B
Drug: Clevudine
Drug: Adefovir dipivoxil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of HBV DNA from the baseline. [ Designated as safety issue: No ]
  • Child-Pugh score improvement [ Designated as safety issue: No ]
  • MELD score improvement [ Designated as safety issue: No ]
  • Biochemical improvement [ Designated as safety issue: No ]
  • Proportion of patients with HBeAg loss and/or seroconversion [ Designated as safety issue: No ]

Estimated Enrollment: 102
Study Start Date: December 2007
Arms Assigned Interventions
Experimental: 1
Clevudine
Drug: Clevudine
30mg
Other Name: Levovir
Active Comparator: 2
Adefovir
Drug: Adefovir dipivoxil
10mg
Other Name: Hepsera

  Eligibility

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

Inclusion Criteria:

  1. Patient is 18 years and older.
  2. 5 ≦ Child-Pugh score ≦ 12
  3. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
  4. Patient is documented to be HBsAg positive for > 6 months.
  5. Patient is HBeAg positive or negative.
  6. Patient has ALT or AST levels which are in the range of > 1 x ULN and < 15 X ULN
  7. Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
  8. Life expectancy of at least 12 months
  9. Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
  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, immunomodulatory, cytotoxic or corticosteroid therapy.
  2. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  3. Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient with clinical evidence of hepatocellular carcinoma
  6. Patient has alpha-fetoprotein > 400ng/mL.
  7. Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm3.
  8. Patient is pregnant or breast-feeding.
  9. 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.
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. Patient with previous liver transplantation
  12. 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.
  13. 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: NCT00672867

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

No publications provided

Responsible Party: --
ClinicalTrials.gov Identifier: NCT00672867     History of Changes
Other Study ID Numbers: L-FMAU-309
Study First Received: May 2, 2008
Last Updated: July 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
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 29, 2014