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Completed

NCT Number: NCT01264107

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Soon Koo Baik

Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, 220-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of patients with sustained antiviral activity effect

    Time frame: at week 48

Secondary outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Bukwang Pharmaceutical

Industry

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 21, 2010
Registry last updated
Jul 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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