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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

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264107
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Phase
Chronic Hepatitis B
 Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with sustained antiviral activity effect [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of sAg [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • Proportion of sAg loss [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • The change of HBV DNA form the baseline [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
    (log copies/mL)

  • Proportion of patients with ALT normalization [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • Proportion of HBeAg loss/seroconversion [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Hee Won Yoo, Bukwang Pharm. Co. Ltd.
ClinicalTrials.gov Identifier: NCT01264107     History of Changes
Other Study ID Numbers: CLV-409
Study First Received: December 19, 2010
Last Updated: July 24, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
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
2'-fluoro-5-methylarabinosyluracil
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013