A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

Sponsor

Bukwang Pharmaceutical (Industry)

Overall Status

Terminated

CT.gov ID

NCT01266005

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a open, randomized, parallel study. Subjects will have Clevudine or Entecavir therapy for 48 weeks(Clevudine:Entecavir = 2:1), and subjects who have Complete Response(HBV DNA negative and ALT normal) will have follow-up period for additional 48 weeks.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: Clevudine Drug: Entecavir	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Study to Compare and Evaluate Intrahepatic cccDNA Reduction After Administrating Clevudine or Entecavir in the Chronic HBV Patients

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Clevudine 30mg	Drug: Clevudine 30mg,QD Other Names: Levovir
Active Comparator: 2 Entecavir 0.5mg	Drug: Entecavir 0.5mg QD Other Names: Baraclude

Arm

Intervention/Treatment

Experimental: 1

Clevudine 30mg

Drug: Clevudine

30mg,QD

Other Names:

Levovir

Active Comparator: 2

Entecavir 0.5mg

Drug: Entecavir

0.5mg QD

Other Names:

Baraclude

Outcome Measures

Primary Outcome Measures

Intrahepatic cccDNA reduction from baseline [week 48]

Secondary Outcome Measures

Proportion of patients with HBV DNA below LOD by real-time PCR [day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)]
Reduction of HBV DNA level from baseline [day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)]
ALT normalization [day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)]
Reduction of sAg titer from baseline [day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)]
Proportion of maintaining sustained effect [every 8 weeks during follow-up period(48weeks)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient who is older than 18.
Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL
Patient who is HBeAg negative.
Patient with ALT≥1×ULN.
Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
Patient is treated with interferon for the previous 6 months.
Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.
Patient is coinfected with HCV, HDV or HIV.
Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.
Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.
Patient has a history of organ transplantation.
Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.
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, allergic disease or medical illness that in the investigator's opinion might interfere with therapy. The patient with a benign tumor, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
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]