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

NCT ID: NCT01266005

Last Updated: 2014-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2014-01-31

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.

Conditions

Chronic Hepatitis B

Keywords

HBe Ag(-) Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Clevudine 30mg

Group Type: EXPERIMENTAL

Clevudine

Intervention Type: DRUG

30mg,QD

2

Entecavir 0.5mg

Group Type: ACTIVE_COMPARATOR

Entecavir

Intervention Type: DRUG

0.5mg QD

Interventions

Clevudine

30mg,QD

Intervention Type: DRUG

Entecavir

0.5mg QD

Intervention Type: DRUG

Other Intervention Names

Levovir; Baraclude

Eligibility Criteria

Inclusion Criteria

1. Patient who is older than 18.

2. Patient who is HBsAg positive for the previous 6 months and with HBV DNA ≥ 1 x 10^5 copies/mL

3. Patient who is HBeAg negative.

4. Patient with ALT≥1×ULN.

5. Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria

1. Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.

2. Patient is treated with interferon for the previous 6 months.

3. Patient has been treated previously with clevudine, lamivudine, adefovir, entecavir, telbivudine or any other investigational nucleoside for HBV infection.

4. Patient is coinfected with HCV, HDV or HIV.

5. Patient has evidence of ascites, variceal hemorrhage and/or hepatic encephalopathy.

6. Patient has evidence of decompensated Liver cirrhosis and/or hepatocellular carcinoma.

7. Patient has a history of organ transplantation.

8. Patient has the treatment of nephrotoxicity drugs, competitive drugs for kidney to excrete, and/or hepatotoxicity drugs for the previous 2 months from screening.

9. Patient is pregnant or breast-feeding.

10. Patient has a clinically relevant history of abuse of alcohol or drugs.

11. 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.

12. 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]

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bukwang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Bukwang Pharm.Co.,LTD

Locations

9 Sites

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CLV-410

Identifier Type: -

Identifier Source: org_study_id