Long-term Study With Clevudine

NCT00558818 | Completed Phase 4

• 1 other identifier: KOR-404
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Interventions

Clevudine DRUG

clevudine 30 mg qd

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

KoreaUniversity Guro Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 15, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 26, 2012

Record last verified: 2012-07

Locations

KR (1)