Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

Hepatitis B Clinical Trial

Official title:

An Open-label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00362505
• Other study ID #: L-FMAU-303
• Status: Terminated
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: January 30, 2017
• Start date: June 2004
• Est. completion date: March 2006

Study information

• Verified date: June 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 clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patient is between 18 and 60, inclusive

2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.

3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.

4. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302.

5. Women of childbearing potential must have a negative serum (ß-HCG) pregnancy test at screening.

6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301

2. Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302

3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.

4. Patients previously treated with a-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.

5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.

6. Patient is coinfected with HCV, HDV or HIV.

7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and a-Fetoprotein > 50 ng/mL

8. Patient is pregnant or breast-feeding.

9. 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) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)

10. Patient has a clinically relevant history of abuse of alcohol or drugs.

11. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.

12. 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]

13.Patient whom investigator consider is not suitable in this study

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	Kangnam Sacred Heart Hospital	Daelim-dong, Yongdeungpo-gu	Seoul
Korea, Republic of	Yeungnam University Medical Center	Daemyoung-dong, Nam-gu	Taegu
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	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	Namdong-Gu
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	Kyungpook National University Medical Hospital	Jung-gu	Daegu
Korea, Republic of	Keimyumg University Dongsan Medical Center	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	Puch'un	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	Guro-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-Gu
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; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.
Secondary	Efficacy:; Proportion of patients with HBV DNA below the assay Limit of Detection; Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain); Proportion of ALT normalization