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

NCT01266005 | Terminated Phase 4

• 1 other identifier: CLV-410
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intrahepatic cccDNA reduction from baseline

  week 48

Secondary Outcomes (5)

• 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)

Study Arms (2)

1

EXPERIMENTAL

Clevudine 30mg

Drug: Clevudine

2

ACTIVE COMPARATOR

Entecavir 0.5mg

Drug: Entecavir

Interventions

Clevudine DRUG

30mg,QD

Also known as: Levovir

1

Entecavir DRUG

0.5mg QD

Also known as: Baraclude

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

9 Sites

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine; entecavir

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2010
• First Posted: December 24, 2010
• Study Start: August 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: January 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

KR (1)