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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313287
• Other study ID #: L-FMAU-301
• Status: Terminated
• Phase: Phase 3
• First received: April 11, 2006
• Last updated: January 30, 2017
• Start date: June 2003
• Est. completion date: November 2004

Study information

• Verified date: April 2006
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 180
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 (ß-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.

11. 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• clevudine

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Ami-dong	Seo-gu, Pusan
Korea, Republic of	Kosin Medical Center	Amnam-dong	Seo-gu, Pusan
Korea, Republic of	Korea University Anam Hospital	Anam-dong	Sungbuk-ku, Seoul
Korea, Republic of	KangNam St. Mary's Hospital	Banpo-dong	Seocho-gu, Seoul
Korea, Republic of	St. Mercy's Hospital	Bupyoung-dong	Bupyoung-gu, Incheon
Korea, Republic of	Yeungnam University Medical Center	Dae myoung-dong	Nam-gu, Taegu
Korea, Republic of	Kangnam Sacred Heart Hospital	Daelim-dong	Yongdeungpo-gu, Seoul
Korea, Republic of	Chungnam National University Hospital	Daesa-dong	Jung-gu, Daechon
Korea, Republic of	Yongdong Severance Hospital	Dogok-dong	Kangnam-gu, Seoul
Korea, Republic of	Pusan Paik Hospital	Gaegeum-dong	Pusan
Korea, Republic of	Korea Cancer Center Hospital	Gongneung-dong	Nowon-gu, Seoul
Korea, Republic of	Nowon Eulji Hospital	Hagye 1-dong	Nowon-gu, Seoul
Korea, Republic of	Chonnam National University Hospital	Hak-1-dong	Dong-gu, Gwangju-si
Korea, Republic of	Soon Chun Hyang University Hospital	Hannam-dong	Yongsan-gu, Seoul
Korea, Republic of	Wonkwang University Hospital	Iksan-City	Jeonbuk
Korea, Republic of	National Cancer Center	Ilsan-gu,	Kyounggi-do
Korea, Republic of	Samsung Medical Center	Ilwon-dong	Songpa-gu, Seoul
Korea, Republic of	Gil Medical Center	Incheon
Korea, Republic of	Seoul Paik Hospital	Jeo-dong	Seoul
Korea, Republic of	Chonbuk National University Hospital	Jeonju-city	Jeonbuk
Korea, Republic of	St. Vincent's Hospital	Ji-dong,	Paldal-gu, Suwon
Korea, Republic of	Keimyumg University Dongsan Medical Center	Jung-gu	Daegu
Korea, Republic of	Kyungpook National University Medical Hospital	Jung-gu	Daegu
Korea, Republic of	Ehwa Womans University Mokdong Hospital	Mok-dong	Yangcheon-gu, Seoul
Korea, Republic of	St. Holly Family Mary's Hospital	Pucheon	Kyounggi-do
Korea, Republic of	Seoul Asan Medical Center	Pungnap-dong	Kangnam-gu, Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Pyoung-dong	Chongro-gu, Seoul
Korea, Republic of	Pochon CHA University Hospital	Seongnam-gu	Kyounggi-do
Korea, Republic of	Korea University Guro Hospital	Seoul	Gro-gu
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	St. Mary's Hospital	Seoul	Yungdungpo-Gu
Korea, Republic of	Severance Hospital	Shinchon- dong	Seodaemun-gu, Seoul
Korea, Republic of	Inha University Hospital	Sinhung-dong	Jung-gu, Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy:change from baseline in HBV DNA (log10) at Week 24
Primary	Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs.
Secondary	Efficacy:
Secondary	Proportion of patients with HBV DNA below the assay Limit of Detection
Secondary	Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain)
Secondary	Proportion of ALT normalization