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

NCT01264094 | Terminated Phase 4

• 1 other identifier: CLV-408
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBV DNA below the assay limit of detection

Secondary Outcomes (4)

• The change of HBV DNA from the baseline.

• Proportion of patients with HBeAg loss and/or seroconversion.

• Biochemical improvement (e.g. ALT normalization).

• Proportion of sAg loss

Interventions

Clevudine DRUG

clevudine 30 mg qd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years and older.
• Patient is documented to be HBsAg positive for \> 6 months and HBV DNA positive.
• Patient is HBeAg positive or negative.
• Patient has ALT levels ≥ 80 IU/L
• Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

You may not qualify if:

• Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
• Patients previously treated with interferon within the previous 3 months.
• Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
• Patient is coinfected with HCV, HDV or HIV.
• Patient is pregnant or breast-feeding.
• 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)

Gangnam Severance 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: December 19, 2010
• First Posted: December 21, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

KR (1)