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An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine

Sponsor
Bukwang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT01264107
Collaborator
(none)
37
Enrollment
1
Location
36
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    37 participants
    Time Perspective:
    Prospective
    Official Title:
    An Open Study to Evaluate the Sustained Effect in Patients Showing Virological Responses With Muscle-related Symptom of Chronic Hepatitis B Patients Who Received Clevudine
    Study Start Date :
    Apr 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2012
    Actual Study Completion Date :
    Apr 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with sustained antiviral activity effect [at week 48]

    Secondary Outcome Measures

    1. The change of sAg [at week 48]

    2. Proportion of sAg loss [at week 48]

    3. The change of HBV DNA form the baseline [at week 48]

      (log copies/mL)

    4. Proportion of patients with ALT normalization [at week 48]

    5. Proportion of HBeAg loss/seroconversion [at week 48]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients is currently clevudine treatment.

    2. Patients with HBV DNA < 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine

    3. 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. Patient is pregnant or breast-feeding.

    3. Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.

    4. Patient, in the opinion of the investigator, unsuitable for the study.

    5. Showing Muscle-related Symptom who any other evidence.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Koo Baik Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do Korea, Republic of 220-701

    Sponsors and Collaborators

    • Bukwang Pharmaceutical

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01264107
    Other Study ID Numbers:
    • CLV-409
    First Posted:
    Dec 21, 2010
    Last Update Posted:
    Jul 26, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Jul 26, 2012