NCT00362700

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2006

Completed
Last Updated

February 1, 2017

Status Verified

June 1, 2006

First QC Date

August 8, 2006

Last Update Submit

January 30, 2017

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (2)

  • Antiviral activity- Change from baseline in HBV DNA (log10)

  • Safety- Laboratory tests, Adverse Events, Vital Signs, ECG

Secondary Outcomes (3)

  • 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)

Interventions

ClevudineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Location

Seoul National University Hospital

Seoul, Jongno-Gu, South Korea

Location

Yongdong Severance Hospital

Dogok-dong, Kangnam-gu, Seoul, South Korea

Location

Samsung Medical Center

Ilwon-dong, Songpa-gu, Seoul, South Korea

Location

Ehwa Womans University Mokdong Hospital

Mok-dong, Yangcheon-gu, Seoul, South Korea

Location

Seoul Asan Medical Center

Pungnap-dong, Kangnam-gu, Seoul, South Korea

Location

Asan Medical Center

P’ungnabi-dong, Songpa-Gu, Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

clevudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Hyo Suk Lee, M.D., Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 10, 2006

Study Start

July 1, 2003

Study Completion

October 1, 2005

Last Updated

February 1, 2017

Record last verified: 2006-06

Locations

KR(7)