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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01264107
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : July 26, 2012
Sponsor:
Information provided by:
Bukwang Pharmaceutical

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 Phase
Chronic Hepatitis B Phase 4

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 : April 2009
Primary Completion Date : January 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Proportion of patients with sustained antiviral activity effect [ Time Frame: at week 48 ]

Secondary Outcome Measures :
  1. The change of sAg [ Time Frame: at week 48 ]
  2. Proportion of sAg loss [ Time Frame: at week 48 ]
  3. The change of HBV DNA form the baseline [ Time Frame: at week 48 ]
    (log copies/mL)

  4. Proportion of patients with ALT normalization [ Time Frame: at week 48 ]
  5. Proportion of HBeAg loss/seroconversion [ Time Frame: at week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264107


Locations
Korea, Republic of
Soon Koo Baik
Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, Korea, Republic of, 220-701
Sponsors and Collaborators
Bukwang Pharmaceutical

Responsible Party: Hee Won Yoo, Bukwang Pharm. Co. Ltd.
ClinicalTrials.gov Identifier: NCT01264107     History of Changes
Other Study ID Numbers: CLV-409
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: July 26, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Clevudine
Antiviral Agents
Anti-Infective Agents