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

July 24, 2012 updated by: Bukwang Pharmaceutical
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, Korea, Republic of, 220-701
        • Soon Koo Baik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with sustained antiviral activity effect
Time Frame: at week 48
at week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of sAg
Time Frame: at week 48
at week 48
Proportion of sAg loss
Time Frame: at week 48
at week 48
The change of HBV DNA form the baseline
Time Frame: at week 48
(log copies/mL)
at week 48
Proportion of patients with ALT normalization
Time Frame: at week 48
at week 48
Proportion of HBeAg loss/seroconversion
Time Frame: at week 48
at week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bukwang Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 19, 2010

First Submitted That Met QC Criteria

December 20, 2010

First Posted (ESTIMATE)

December 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLV-409

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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