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Clinical Trials/NCT01266005
NCT01266005TerminatedPhase 4

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

Bukwang Pharmaceutical1 site in 1 country75 target enrollmentStarted: August 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
Intrahepatic cccDNA reduction from baseline
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient who is older than
  • •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]

Arms & Interventions

1

Experimental

Clevudine 30mg

Intervention: Clevudine (Drug)

2

Active Comparator

Entecavir 0.5mg

Intervention: Entecavir (Drug)

Outcomes

Primary Outcomes

Intrahepatic cccDNA reduction from baseline

Time Frame: week 48

Secondary Outcomes

  • 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))

Investigators

Sponsor
Bukwang Pharmaceutical
Sponsor Class
Industry

Study Sites (1)

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