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

Completed

• Conditions: Chronic Hepatitis B

• Registration Number: NCT01264107
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-12-19
• Study First Submitted QC: 2010-12-20
• Study First Posted: 2010-12-21
• Primary Completion: 2012-01
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with sustained antiviral activity effect	at week 48

Secondary Outcome Measures

Name	Time	Method
The change of sAg	at week 48
Proportion of sAg loss	at week 48
The change of HBV DNA form the baseline	at week 48	(log copies/mL)
Proportion of patients with ALT normalization	at week 48
Proportion of HBeAg loss/seroconversion	at week 48

Trial Locations

Locations (1)

Soon Koo Baik; 🇰🇷 Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do, Korea, Republic of