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Clinical Trials/NCT01264107
NCT01264107
Completed
Not Applicable

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

Bukwang Pharmaceutical1 site in 1 country37 target enrollmentApril 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Hepatitis B
Sponsor
Bukwang Pharmaceutical
Enrollment
37
Locations
1
Primary Endpoint
Proportion of patients with sustained antiviral activity effect
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
April 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bukwang Pharmaceutical

Eligibility Criteria

Inclusion Criteria

  • Patients is currently clevudine treatment.
  • Patients with HBV DNA \< 300 cpoies/mL and ALT normal Showing Muscle-related Symptom Who received Clevudine
  • Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

  • Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  • Patient is pregnant or breast-feeding.
  • Patient has a significant gastrointestinal, renal, decompensated liver, bronchopulmonary, neurological, cardiac, oncologic(except HCC)or allergic disease.
  • Patient, in the opinion of the investigator, unsuitable for the study.
  • Showing Muscle-related Symptom who any other evidence.

Outcomes

Primary Outcomes

Proportion of patients with sustained antiviral activity effect

Time Frame: at week 48

Secondary Outcomes

  • The change of sAg(at week 48)
  • Proportion of sAg loss(at week 48)
  • The change of HBV DNA form the baseline(at week 48)
  • Proportion of patients with ALT normalization(at week 48)
  • Proportion of HBeAg loss/seroconversion(at week 48)

Study Sites (1)

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