Clinical trial NCT00362674: Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2006-08-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who completed the previous 301, 302 and 303 studies with clevudine

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jung-gu,
country: Korea, Republic of
facility: Keimyumg University Dongsan Medical Center
state: Daegu
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
city: Bupyoung-dong, Bupyoung-gu
country: Korea, Republic of
facility: St. Mercy's Hospital
state: Incheon
city: Sinhung-dong, Jung-gu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
city: Iksan-City
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeonbuk
city: Jeonju-city
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeonbuk
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-Gu
city: Ilsan-gu
country: Korea, Republic of
facility: National Cancer Center
state: Kyounggi-do
city: Pucheon
country: Korea, Republic of
facility: St. Holly Family Mary's Hospital
state: Kyounggi-do
city: Seongnam-gu
country: Korea, Republic of
facility: Pochon CHA University Hospital
state: Kyounggi-do
city: Incheon
country: Korea, Republic of
facility: Gil Medical Center
state: Namdong-Gu
city: Hagye 1-dong
country: Korea, Republic of
facility: Nowon Eulji Hospital
state: Nowon-gu, Seoul
city: Ami-dong, Seo-gu
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan
city: Amnam-dong, Seo-gu
country: Korea, Republic of
facility: Kosin Medical Center
state: Pusan
city: Anam-dong, Sungbuk-ku
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul
city: Daelim-dong, Yongdeungpo-gu
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
state: Seoul
city: Dogok-dong, Kangnam-gu
country: Korea, Republic of
facility: Yongdong Severance Hospital
state: Seoul
city: Gongneung-dong, Nowon-gu
country: Korea, Republic of
facility: Korea Cancer Center Hospital
state: Seoul
city: Ilwon-dong, Songpa-gu
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul
city: Jeo-dong
country: Korea, Republic of
facility: Seoul Paik Hospital
state: Seoul
city: Mok-dong, Yangcheon-gu
country: Korea, Republic of
facility: Ehwa Womans University Mokdong Hospital
state: Seoul
city: Pungnap-dong, Kangnam-gu
country: Korea, Republic of
facility: Seoul Asan Medical Center
state: Seoul
city: Pyoung-dong, Chongro-gu,
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
state: Seoul
city: Shinchon- dong, Seodaemun-gu
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
city: Ji-dong,, Paldal-gu
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Suwon
city: Daemyoung-dong, Nam-gu
country: Korea, Republic of
facility: Yeungnam University Medical Center
state: Taegu
city: Seoul
country: Korea, Republic of
facility: St. Mary's Hospital
state: Yungdungpo-Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-suk Lee, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References: