A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Chronic Hepatitis B Clinical Trial

Official title:

A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01264094
• Other study ID #: CLV-408
• Status: Terminated
• Phase: Phase 4
• First received: December 19, 2010
• Last updated: July 20, 2015
• Start date: November 2009
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea:Korea Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient is 18 years and older.

2. Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.

3. Patient is HBeAg positive or negative.

4. Patient has ALT levels = 80 IU/L

5. 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. Patients previously treated with interferon within the previous 3 months.

3. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.

4. Patient is coinfected with HCV, HDV or HIV.

5. Patient is pregnant or breast-feeding.

6. Patient has a clinically relevant history of abuse of alcohol or drugs.

7. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.

8. Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Clevudine
clevudine 30 mg qd

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital	Seoul

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 HBV DNA below the assay limit of detection			No
Secondary	The change of HBV DNA from the baseline.			No
Secondary	Proportion of patients with HBeAg loss and/or seroconversion.			No
Secondary	Biochemical improvement (e.g. ALT normalization).			No
Secondary	Proportion of sAg loss			No