Long-term Study With Clevudine

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558818
• Other study ID #: KOR-404
• Secondary ID: KOR-404
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2007
• Last updated: July 24, 2012
• Start date: June 2007
• Est. completion date: September 2011

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: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 (ß-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]

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Clevudine
clevudine 30 mg qd

Locations

Country	Name	City	State
Korea, Republic of	KoreaUniversity Guro 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 by Real-time PCR		Screening, day1,every 12 weeks during treatment period(96weeks)	No
Secondary	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		Screening, day1, every 12 weeks during treatment period(96 weeks)	Yes