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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264107
• Other study ID #: CLV-409
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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