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Long-term Study With Clevudine

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clevudine

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline.
Patient is documented to be HBsAg positive for > 6 months.
Patient has ALT levels >=80 IU/L
Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy.

Exclusion Criteria.

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patients previously treated with interferon within the previous 6 months.
Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
Patient is coinfected with HCV, HDV or HIV.
Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
Patient is pregnant or breast-feeding.
Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
Patient has a clinically relevant history of abuse of alcohol or drugs.
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.
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]

Sites / Locations

KoreaUniversity Guro Hospital

Outcomes

Primary Outcome Measures

Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR

Secondary Outcome Measures

Antiviral activity : change from baseline in HBV DNA (log10 copies/mL)Biochemical improvement (e.g. ALT normalization)Proportion of patients with HBeAg loss and/or seroconversionClevudine-related mutation

Full Information

NCT ID

NCT00558818

First Posted

November 14, 2007

Last Updated

July 24, 2012

Sponsor

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00558818

Brief Title

Long-term Study With Clevudine

Official Title

A Phase lV Study to Evaluate the Long-term Safety and Efficacy of Clevudine in the Patients Chronically Infected With Hepatitis B Virus

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A open-labeled phase lV study with 96 weeks of treatment period. The purpose of this study is to investigate safety and efficacy of clevudine in patients chronically infected with hepatitis B virus, HBeAg positive or negative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clevudine

Intervention Description

clevudine 30 mg qd

Primary Outcome Measure Information:

Title

Proportion of patients with HBV DNA below the assay limit of detection by Real-time PCR

Time Frame

Screening, day1,every 12 weeks during treatment period(96weeks)

Secondary Outcome Measure Information:

Title

Time Frame

Screening, day1, every 12 weeks during treatment period(96 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patient with DNA levels >=1 x 10^5 copies/mL within 30 days of baseline. Patient is documented to be HBsAg positive for > 6 months. Patient has ALT levels >=80 IU/L Women of childbearing potential must have a negative urine (β-HCG) pregnancy test taken within 14 days of starting therapy. Exclusion Criteria. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. Patients previously treated with interferon within the previous 6 months. Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma Patient is pregnant or breast-feeding. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. Patient has a clinically relevant history of abuse of alcohol or drugs. 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. 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]

Facility Information:

Facility Name

KoreaUniversity Guro Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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Long-term Study With Clevudine

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