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

Primary Purpose

Chronic Hepatitis B

Status

Terminated

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Clevudine

Entecavir

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring HBe Ag(-) Chronic Hepatitis B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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]

Sites / Locations

9 Sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Clevudine 30mg

Entecavir 0.5mg

Outcomes

Primary Outcome Measures

Intrahepatic cccDNA reduction from baseline

Secondary Outcome Measures

Proportion of patients with HBV DNA below LOD by real-time PCR

Reduction of HBV DNA level from baseline

ALT normalization

Reduction of sAg titer from baseline

Proportion of maintaining sustained effect

Full Information

NCT ID

NCT01266005

First Posted

December 19, 2010

Last Updated

December 16, 2014

Sponsor

Bukwang Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT01266005

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Terminated

Study Start Date

August 2009 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bukwang Pharmaceutical

4. Oversight

5. 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.

6. Conditions and Keywords

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

Chronic Hepatitis B

Keywords

HBe Ag(-) Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Clevudine 30mg

Arm Title

Arm Type

Active Comparator

Arm Description

Entecavir 0.5mg

Intervention Type

Drug

Intervention Name(s)

Clevudine

Other Intervention Name(s)

Levovir

Intervention Description

30mg,QD

Intervention Type

Drug

Intervention Name(s)

Entecavir

Other Intervention Name(s)

Baraclude

Intervention Description

0.5mg QD

Primary Outcome Measure Information:

Title

Intrahepatic cccDNA reduction from baseline

Time Frame

week 48

Secondary Outcome Measure Information:

Title

Proportion of patients with HBV DNA below LOD by real-time PCR

Time Frame

day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)

Title

Reduction of HBV DNA level from baseline

Time Frame

day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)

Title

ALT normalization

Time Frame

day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)

Title

Reduction of sAg titer from baseline

Time Frame

day1(predose), every 12 weeks during treatment period(48weeks), every 8 weeks during follow-up period(48weeks)

Title

Proportion of maintaining sustained effect

Time Frame

every 8 weeks during follow-up period(48weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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]

Facility Information:

Facility Name

9 Sites

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

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

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