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Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

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 clevudine in L-FMAU-201 clinical trial (phase IIb) Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy. Patient is 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: HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval) Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc. Patient is pregnant or breast-feeding. 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. 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 spermicide or abstinence) Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. 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]

Sites / Locations

  • Korea University Guro Hospital
  • Seoul National University Hospital
  • Yongdong Severance Hospital
  • Samsung Medical Center
  • Ehwa Womans University Mokdong Hospital
  • Seoul Asan Medical Center
  • Asan Medical Center

Outcomes

Primary Outcome Measures

Antiviral activity- Change from baseline in HBV DNA (log10)
Safety- Laboratory tests, Adverse Events, Vital Signs, ECG

Secondary Outcome Measures

Antiviral activity- 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
August 8, 2006
Last Updated
January 30, 2017
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00362700
Brief Title
Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201
Official Title
An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of Retreated Clevudine in Chronic Hepatitis B Patients Who Received Clevudine in L-FMAU-201
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Terminated
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 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 determine the safety and antiviral activity of Clevudine, when retreated to patients previously treated with Clevudine

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
Enrollment
33 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clevudine
Primary Outcome Measure Information:
Title
Antiviral activity- Change from baseline in HBV DNA (log10)
Title
Safety- Laboratory tests, Adverse Events, Vital Signs, ECG
Secondary Outcome Measure Information:
Title
Antiviral activity- 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 clevudine in L-FMAU-201 clinical trial (phase IIb) Female of childbearing potential must have a negative serum ( b-HCG) pregnancy test within 14 days of starting therapy. Patient is 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: HBV DNA negative (< 4,700 copies/mL) consistently at the last 2 visit (at least 2 consecutive visits, at one month interval) Patient is currently receiving antiviral immunomodulatory or corticosteroid therapy. Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patient is coinfected with HCV, HDV or HIV. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein) Evaluation will be based on alpha-fetoprotein primarily. If alpha-fetoprotein level is suggestive of cirrhosis or hepatocellular carcinoma, confirmation will be made with sonography etc. Patient is pregnant or breast-feeding. 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. 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 spermicide or abstinence) Patient has a clinically relevant history of abuse of alcohol or drugs. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. 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]
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
Seoul
State/Province
Guro-gu
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Jongno-Gu
Country
Korea, Republic of
Facility Name
Yongdong Severance Hospital
City
Dogok-dong, Kangnam-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Ilwon-dong, Songpa-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Ehwa Womans University Mokdong Hospital
City
Mok-dong, Yangcheon-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Seoul Asan Medical Center
City
Pungnap-dong, Kangnam-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Pungnab2-dong
State/Province
Songpa-Gu, Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Retreated Clevudine in Chronic HBV Patients Who Received Clevudine in L-FMAU-201

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