Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group

Hepatitis B Clinical Trial

Official title:

An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00313261
• Other study ID #: L-FMAU-203
• Status: Terminated
• Phase: Phase 2
• First received: April 11, 2006
• Last updated: October 16, 2012
• Start date: June 2003
• Est. completion date: February 2005

Study information

• Verified date: October 2012
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients who received placebo in L-FMAU-201 study

2. Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy.

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

4. 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:

1. Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study.

2. Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy.

3. Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.

4. Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy.

5. Patient who was co-infected with HCV, HDV or HIV.

6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.

7. Patient who was pregnant or breast-feeding.

8. Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. 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 supermicide or abstinence)

9. Patient who had a clinically relevant history of abuse of alcohol or drugs.

10. Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.

11. Patient who had 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]

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Intervention

Drug:
• Clevudine

Locations

Country	Name	City	State
Korea, Republic of	Yongdong Severance Hospital	Dogok-dong	Kangnam-Gu, Seoul
Korea, Republic of	Korea University Guro Hospital	Guro-dong	Guro-ku, Seoul
Korea, Republic of	Samsung Medical Center	Ilwon-dong	Kangnam-Gu, Seoul
Korea, Republic of	Ewha Womans University Hospital	Mok-dong	Yangchon-Gu, Seoul
Korea, Republic of	Asan Medical Center	Pungnab2-dong	Songpa-Gu, Seoul
Korea, Republic of	Seoul National University	Yeongeon-dong	Jongno-Gu, Seoul
Korea, Republic of	St. Mary's Hospital	Youido	Yougdungpo-Gu, Seoul

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)
Primary	Safety: Laboratory tests, Adverse Events, Vital Signs, ECG
Secondary	Efficacy
Secondary	Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
Secondary	Biochemical improvement (ALT normalization)
Secondary	Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)