Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

Hepatitis B Clinical Trial

Official title:

An Open-label, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00362674
• Other study ID #: CLV-304
• Status: Completed
• Phase: N/A
• First received: August 8, 2006
• Last updated: January 30, 2017
• Start date: June 2005

Study information

• Verified date: December 2010
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.

2. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.

3. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303

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

5. Patients with 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 at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.

Exclusion Criteria:

1. Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.

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

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

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

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

6. Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.

7. Patients who were pregnant or breast-feeding.

8. Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, 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.

9. Patients who were not suitable to the study if judged by an investigator.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

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	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	Yongdong Severance Hospital	Dogok-dong, Kangnam-gu	Seoul
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	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	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	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	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,