A Pilot Study to Evaluate the Safety and Efficacy of Clevudine or Adefovir Patients With LC-B

December 17, 2014 updated by: Bukwang Pharmaceutical

A Open Randomized Clinical Trial Comparing the Efficacy and Safety of Clevudine 30mg Versus Adefovir 10mg in Patients With LC-B

The purpose of this study is to compare the safety and antiviral activity of Clevudine Versus Adefovir dipivoxil in patients with LC-B.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is 18 years and older.
  2. 5 ≦ Child-Pugh score ≦ 12
  3. Patient is HBV DNA positive with DNA levels ≥ 1 x 10(4) copies/mL within 30 days of baseline.
  4. Patient is documented to be HBsAg positive for > 6 months.
  5. Patient is HBeAg positive or negative.
  6. Patient has ALT or AST levels which are in the range of > 1 x ULN and < 15 X ULN
  7. Patient with liver cirrhosis diagnosed by imaging study within 1 year or clinical evidence of portal hypertension
  8. Life expectancy of at least 12 months
  9. Female patient with a negative urine(Beta-HCG) pregnancy test taken within 14 days of starting therapy.
  10. 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. Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
  3. Patients previously treated with clevudine, entecavir, lamivudine, adefovir, telbivudine or any other investigational nucleoside for HBV infection.
  4. Patient is coinfected with HCV, HDV or HIV.
  5. Patient with clinical evidence of hepatocellular carcinoma
  6. Patient has alpha-fetoprotein > 400ng/mL.
  7. Patient has Hemoglobin <8g/dL (Male), 7.5g/dL (Female) or WBC <1,500mm3 or Neutrophils <500/mm3 or Platelet count <30,000/mm3.
  8. Patient is pregnant or breast-feeding.
  9. Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases.
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. Patient with previous liver transplantation
  12. Patient has a significant immunocompromised, gastrointestinal, renal, hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
  13. 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]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Clevudine
30mg
Other Names:
  • Levovir
Active Comparator: 2
Adefovir
10mg
Other Names:
  • Hepsera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of patients with HBV DNA below 12 IU/mL by Real-Time PCR

Secondary Outcome Measures

Outcome Measure
The change of HBV DNA from the baseline.
Child-Pugh score improvement
MELD score improvement
Biochemical improvement
Proportion of patients with HBeAg loss and/or seroconversion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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