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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01264107
Other study ID # CLV-409
Secondary ID
Status Completed
Phase Phase 4
First received December 19, 2010
Last updated July 24, 2012
Start date April 2009
Est. completion date April 2012

Study information

Verified date July 2012
Source Bukwang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date April 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Time Perspective: Prospective


Locations

Country Name City State
Korea, Republic of Soon Koo Baik Wonju, Kangwon-do 162 Ilsan-dong, Wonju, Kangwon-do

Sponsors (1)

Lead Sponsor Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with sustained antiviral activity effect at week 48 No
Secondary The change of sAg at week 48 No
Secondary Proportion of sAg loss at week 48 No
Secondary The change of HBV DNA form the baseline (log copies/mL) at week 48 No
Secondary Proportion of patients with ALT normalization at week 48 No
Secondary Proportion of HBeAg loss/seroconversion at week 48 No
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