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Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group

Primary Purpose

Hepatitis B

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Clevudine
Sponsored by
Bukwang Pharmaceutical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who received placebo in L-FMAU-201 study Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy. Patients who were able to give written informed consent prior to study start and to comply with the study requirements. Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48 Exclusion Criteria: Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study. Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study. Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient who was co-infected with HCV, HDV or HIV. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc. Patient who was pregnant or breast-feeding. Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with supermicide or abstinence) Patient who had a clinically relevant history of abuse of alcohol or drugs. Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. Patient who had 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

  • Korea University Guro Hospital
  • Seoul National University
  • Yongdong Severance Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Ewha Womans University Hospital
  • St. Mary's Hospital

Outcomes

Primary Outcome Measures

Efficacy: Change from baseline in HBV DNA (log10)
Safety: Laboratory tests, Adverse Events, Vital Signs, ECG

Secondary Outcome Measures

Efficacy
Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
Biochemical improvement (ALT normalization)
Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)

Full Information

First Posted
April 11, 2006
Last Updated
October 16, 2012
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00313261
Brief Title
Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group
Official Title
An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Terminated
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bukwang Pharmaceutical

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clevudine
Primary Outcome Measure Information:
Title
Efficacy: Change from baseline in HBV DNA (log10)
Title
Safety: Laboratory tests, Adverse Events, Vital Signs, ECG
Secondary Outcome Measure Information:
Title
Efficacy
Title
Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
Title
Biochemical improvement (ALT normalization)
Title
Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who received placebo in L-FMAU-201 study Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy. Patients who were able to give written informed consent prior to study start and to comply with the study requirements. Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60: 1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48 Exclusion Criteria: Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study. Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study. Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient who was co-infected with HCV, HDV or HIV. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc. Patient who was pregnant or breast-feeding. Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with supermicide or abstinence) Patient who had a clinically relevant history of abuse of alcohol or drugs. Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. Patient who had 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]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo Suk Lee, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Guro Hospital
City
Guro-dong
State/Province
Guro-ku, Seoul
Country
Korea, Republic of
Facility Name
Seoul National University
City
Yeongeon-dong
State/Province
Jongno-Gu, Seoul
Country
Korea, Republic of
Facility Name
Yongdong Severance Hospital
City
Dogok-dong
State/Province
Kangnam-Gu, Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Ilwon-dong
State/Province
Kangnam-Gu, Seoul
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Pungnab2-dong
State/Province
Songpa-Gu, Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Hospital
City
Mok-dong
State/Province
Yangchon-Gu, Seoul
Country
Korea, Republic of
Facility Name
St. Mary's Hospital
City
Youido
State/Province
Yougdungpo-Gu, Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group

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