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Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBV

Sponsor
Bukwang Pharmaceutical (Industry)
Overall Status
Terminated
CT.gov ID
NCT00313287
Collaborator
(none)
180
Enrollment
33
Locations
17.1
Duration (Months)
5.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine safety and efficacy of 30 mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in patients with chronic HBV.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 mg QD in Patients Chronically Infected With Hepatitis B Virus
Study Start Date :
Jun 1, 2003
Study Completion Date :
Nov 1, 2004

Outcome Measures

Primary Outcome Measures

  1. Efficacy:change from baseline in HBV DNA (log10) at Week 24 []

  2. Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs. []

Secondary Outcome Measures

  1. Efficacy: []

  2. Proportion of patients with HBV DNA below the assay Limit of Detection []

  3. Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain) []

  4. Proportion of ALT normalization []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Patients who were between 18 and 60, inclusive.

  2. Patients with HBV DNA ³1 x 106 copies/mL within 30 days of baseline.

  3. Patients who were documented to be HBsAg positive for > 6 months. (The documentation of positive HBsAg for the previous 6 months included previous laboratory reports of HBsAg positive or HBeAg positive at least 6 month ago or IgM anti-HBc negative and IgG anti-HBc positive at screening).

  4. Patients who were HBeAg positive.

  5. Patients with ALT levels which were in the range of ≥1.2 and < 15 times of the upper limit of normal (x ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL.

  6. Women of child bearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.

  7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.

  2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.

  3. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.

  4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.

  5. Patients co-infected with HCV, HDV or HIV.

  6. Patients with clinical evidence of liver mass or with alpha-fetoprotein > 50 ng/mL

  7. Patients who were pregnant or breast-feeding.

  8. Patients who were unwilling to use an "effective" method of contraception during the treatment and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception ( i.e. IUD, barrier methods with spermicide or abstinence)

  9. Patients with a clinically relevant history of abuse of alcohol or drugs.

  10. Patients with a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease.

The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.

  1. Patients with 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]

Patients who were found to have YMDD HBV DNA polymerase mutation at baseline were to be excluded from the overall efficacy evaluation and analyzed separately. They were to be included in the overall safety evaluation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Mercy's Hospital Bupyoung-dong Bupyoung-gu, Incheon Korea, Republic of
2 Kangbuk Samsung Hospital Pyoung-dong Chongro-gu, Seoul Korea, Republic of
3 Keimyumg University Dongsan Medical Center Jung-gu Daegu Korea, Republic of
4 Kyungpook National University Medical Hospital Jung-gu Daegu Korea, Republic of
5 Chonnam National University Hospital Hak-1-dong Dong-gu, Gwangju-si Korea, Republic of
6 Korea University Guro Hospital Seoul Gro-gu Korea, Republic of
7 Wonkwang University Hospital Iksan-City Jeonbuk Korea, Republic of
8 Chonbuk National University Hospital Jeonju-city Jeonbuk Korea, Republic of
9 Chungnam National University Hospital Daesa-dong Jung-gu, Daechon Korea, Republic of
10 Inha University Hospital Sinhung-dong Jung-gu, Incheon Korea, Republic of
11 Yongdong Severance Hospital Dogok-dong Kangnam-gu, Seoul Korea, Republic of
12 Seoul Asan Medical Center Pungnap-dong Kangnam-gu, Seoul Korea, Republic of
13 National Cancer Center Ilsan-gu, Kyounggi-do Korea, Republic of
14 St. Holly Family Mary's Hospital Pucheon Kyounggi-do Korea, Republic of
15 Pochon CHA University Hospital Seongnam-gu Kyounggi-do Korea, Republic of
16 Yeungnam University Medical Center Dae myoung-dong Nam-gu, Taegu Korea, Republic of
17 Korea Cancer Center Hospital Gongneung-dong Nowon-gu, Seoul Korea, Republic of
18 Nowon Eulji Hospital Hagye 1-dong Nowon-gu, Seoul Korea, Republic of
19 St. Vincent's Hospital Ji-dong, Paldal-gu, Suwon Korea, Republic of
20 Pusan Paik Hospital Gaegeum-dong Pusan Korea, Republic of
21 Pusan National University Hospital Ami-dong Seo-gu, Pusan Korea, Republic of
22 Kosin Medical Center Amnam-dong Seo-gu, Pusan Korea, Republic of
23 KangNam St. Mary's Hospital Banpo-dong Seocho-gu, Seoul Korea, Republic of
24 Severance Hospital Shinchon- dong Seodaemun-gu, Seoul Korea, Republic of
25 Seoul Paik Hospital Jeo-dong Seoul Korea, Republic of
26 Samsung Medical Center Ilwon-dong Songpa-gu, Seoul Korea, Republic of
27 Korea University Anam Hospital Anam-dong Sungbuk-ku, Seoul Korea, Republic of
28 Ehwa Womans University Mokdong Hospital Mok-dong Yangcheon-gu, Seoul Korea, Republic of
29 Kangnam Sacred Heart Hospital Daelim-dong Yongdeungpo-gu, Seoul Korea, Republic of
30 Soon Chun Hyang University Hospital Hannam-dong Yongsan-gu, Seoul Korea, Republic of
31 St. Mary's Hospital Seoul Yungdungpo-Gu Korea, Republic of
32 Gil Medical Center Incheon Korea, Republic of
33 Seoul National University Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Bukwang Pharmaceutical

Investigators

  • Principal Investigator: Hyo-Suk Lee, MD. PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00313287
Other Study ID Numbers:
  • L-FMAU-301
First Posted:
Apr 12, 2006
Last Update Posted:
Feb 1, 2017
Last Verified:
Apr 1, 2006
Additional relevant MeSH terms:
Hepatitis B
Hepatitis
Clevudine

Study Results

No Results Posted as of Feb 1, 2017