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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014